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Thursday, July 30, 2020

Best Fellowships for Pharm.D (Doctor of Pharmacy) and MBBS


Best Fellowships after Pharm.D (Doctor of Pharmacy) and MBBS

 

Most of us are aware that we can do MD which is in abroad and some may be thinking of doing a Ph.D. but other than this there is no idea on what to do after Pharm D so in this blog we will discuss about something about fellowships or residency programs that are available in India

           yes, you heard it right. Scholarships or Residency programs are one of the golden opportunities for the Indian Pharm.D graduates to specialize themselves and gain a thorough knowledge of specialized departments like 

      Residency Program is a structured, directed, salaried postgraduate training program in pharmacy a practice that typically lasts one or two years. This program focuses mainly on the development of competency skills and application of drug therapy knowledge in providing a broad scope of pharmaceutical services to the patients as simple it is the program which expertise the Pharm D graduates on specialized areas like Oncology, Nephrology, etc.,

These fellowships are generally divided into two parts postgraduate year one and postgraduate year 2

          so in the first year of the program, the PharmD graduates will be doing their regular internships from 2nd-year students will be trained under any specialized clinical area by the dedicated clinical practitioners or Doctors.

         During these Residency programs, students will be paid for their service, and only if the minimum number of students will be taken for Residency Program may be one or two per year, so there is a high competition for this type of Fellowship program.


We came across four

1. JSS  Academy Of Higher Education and Research

2. Sri Shankara Cancer Hospital and Research Centre, Bengaluru

3. HCG cancer hospital, Banglore

4. Tata Memorial Centre for advanced treatment Research and Education in Cancer, Navi Mumbai

 let's look at these individual institutions in details and what are their requirements to join this fellowship program

1. JSS Academy Of Higher Education and Research 

JSS Provides a two-year fellowship/residency program after Pharm D in oncotherapy and Nephrology. It is called a "

 The main aim of this Fellowship is:

1. To advance knowledge develop skills and competencies to practice efficiently after pharmacy graduation

2. To provide training to Pharmacy graduates on specialty pharmacy practice

3. To be competent in managing daily clinical pharmacy services in an oncology care setting.

 Duration of the course is 2 years which is divided into 

1.First-year: training and exposure in clinical pharmacy practice in the diverse patient population 

2.Second-year: specialty training and exposure in clinical pharmacy practice in oncology

 Eligibility:

1. Pharm D degree with a minimum the aggregate of 60 percent are eligible for the fellowship

2. The applicant should be a registered pharmacist

where a stipend of 15,000 per month is provided for the student for 2 years as fellowship.

 

Pharm D fellowship

 

 2.Sri Shankara Cancer Hospital and Research Center Fellowship 

which offers Fellowship in oncology for Pharm D graduates, which is of 18 months duration, and there are only two seats available.

Pharm D Fellowships

  3. Hcg cancer hospital, Fellowship.

Eligibility for the Program: A candidate who has completed a Pharm.D degree with minimum aggregate marks of 60% (aggregate of 5 years) from any Pharmacy College Approved by Pharmacy Council of India, New Delhi, and affiliated to a recognized university.

            HCG offers a 2 year fellowship program in oncotherapy where the first year includes a classroom study along with the hospital visits. In contrast, a second-year is entirely dedicated to hospital work or internship, where the student will put forward his gained knowledge into practical aspects.

 

Pharm D Fellowship

4.  Tata Memorial Cancer Hospital, Fellowship.

          It is one of the premier institutes in the country that offers the fellowship program in oncotherapy with is of one year's duration, and there is only one seat available in the institute where the eligibility is pharm D or MD in Pharmacology. Pharm.D graduates will be paid 53,000 per month, and MD Pharmacology graduate will be provided a 65,000 per month stipend during the study.

In this article, we have shared the opportunities for the students after graduating from pharm D in India we have so far got four institutes from our research if you have more suggestion or any institutes that you know which provide the fellowship programs in India you can kindly message in the comment box which will be helpful for the needy graduates.

Pharm D Fellowship

Disclaimer: We collected information about all the fellowships from various sources. Please do check the official websites of those institutions for updated information about those fellowships. This information is just for awareness purposes only, not endorsing any institute.

Please support us by following through your mail id and Comment, What's your opinion on these fellowships.

Share this article with your Pharma friends. Thank you

If you didn't go through my previous articles, please go through the below-mentioned links.


Click Here to know about career opportunities for Pharm.D


Click Here to know about How to choose top-notch research work in 5th Year Pharm D


Click Here to know about Short term courses after B Pharm or Pharm D (Doctor of Pharmacy)


Monday, July 27, 2020

Short term courses after B Pharm or Pharm D (Doctor of Pharmacy)


Short term courses after B Pharm or Pharm D (Doctor of Pharmacy)

Many Pharmacy students will rack their brains about what to do after Completion of their B Pharm or Pharm D. They will be fighting tooth and nails to get good jobs and salary and also in search of excellent skills and extra other short period certification courses. Before getting into content,   I came up with a notification from the Indian government released on 16th July 2019. This is exclusively for Pharm D students, which says that Pharm D doctors and B pharm.. or M pharm are one and the same. I mean they can enter any job sectors where B pharm or M pharm students are eligible. So It is suggesting that PharmDians are also eligible to study some courses which Bpharm or Mpharm people opt after completion, of their course. Let's get started. 

I shortlisted some of the short term courses with a duration of not more than 2 years, i.e., associate degree or diploma courses or less than a year in the count of the month, i.e., program. Many people do not know about some of these courses.

 Now we can see one by one course in detail.

 1)  Medical coding

 Medical coding is the transformation of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes. The diagnoses and procedure codes are taken from medical record documentation, such as transcription of physician's notes, laboratory, and radiologic results, etc. This course has many divisions like CPC, CAC, HPCS, and so on, depending upon Jobs required.
Jobs: as a Medical coder in clinical research fields, pharmaceutical companies, Hospitals & doctors' offices, Healthcare consulting services, Educational institutions, Insurance agencies, Law firms, Government agencies, Work-from-home medical coding.
Salary of Medical coders at the beginning is approximately Rs. 15-20000/-, further, it may increase your experience.

2) Medical billing :

Medical billing translates a healthcare service into a billing claim. Medical billing is the process of submitting and following up on claims with health insurance companies to receive payment for services rendered by a healthcare provider.
Courses: similar to coding courses
Both medical coding and medical billing courses can be learned together. Because the coders and billers in hospital sectors together have a variety of tasks. The primary difference, however, is that medical coders translate medical services into codes, while medical billers translate the claims from these codes into reimbursements from insurance and patients.
Jobs: most fields and sectors where medical coders are present and especially in hospitals and health sectors.

3) Medical writing: 

If you have great writing skills, I suggest this course. Medical writing involves writing scientific documents of different types, which include regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines, or news ...
Duration of course:-3-6 months candidate is expected to complete the course in a minimum of three and a maximum of six months.
Jobs:- Medical journalism, publications, and presentations, research documents, regulatory documents, medical marketing of health care products.
Salary: 20-25 k/month, in the beginning , goes up to 1 lakhs/month upon your experience and skills.

4)Clinical SAS / SAS Clinical 

Clinical SAS is the application of SAS technology to the clinical domain for clinical trial data analysis in pharmaceutical/biotech and clinical research companies. It is used to organize, standardize, and manage clinical research data. SAS Clinical helps to analyze data sets and support strategic analyses.
Course duration: Clinical SAS training takes a maximum of 2 to 3 months.
 Job opportunities: As a clinical SAS programmer in pharmaceutical Industries, clinical research companies, clinical trials
Salary: of the job is initially when you begin the job, your pay scale maybe 2-3 lakhs per annum, later after 2-3 years of experience, it may increase up to 4-5 lakh per annum.

 5) Pharmacovigilance :

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, and medication errors.
 Duration: certificate course takes four months, and pg diploma course takes one year to 1 and a half years.
 Jobs: Clinical research fields and pharmaceutical companies.
Salary: A jobholder in this field can quickly get the starting salary of Rs.3.5 - Rs.8 lakhs per annum. As more recognition is given to drug safety all over the world, jobs in India in this field are increasing in number.

6) Nutrition and dietetics: 

Nutrition and Dietetics is a field in medical science that helps in keeps individuals fit. Nutrition is the study of nutrients in the food, how the body uses nutrients, and the relationship between diet, health, and diseases. The interpretation and communication of the science of nutrition so that people can make practical choices about food and lifestyle in both health and disease.

Duration of course: 1 year to 3 years based on the type of class like a diploma, degree, or Master's degree in nutrition and dietetics.
 Jobs: available as nutritionist and dietitian In health sectors, and also in fitness centers.
 Salary: of Nutritionist and dietitian is 16 k to 20 k at the beginning, and with experience, after 4-5 years, your salary may go up to 40-50 k.

7) Pharmaceutical Marketing and management :

  This is A program that combines the study of primary and pharmaceutical sciences with marketing and management studies, and that prepares individuals for careers in pharmaceutical sales, marketing, management, and related fields within the health care industry.
 Course duration: is about 4-6 months for the certification course and one year for a pg diploma course. And guys, there is also an MBA in Pharmaceutical Marketing and management, a post-graduate course with a duration of 2 years.
 Jobs: pharma company marketing manager, pharma eCommerce jobs, and Marketing and management related jobs in Pharma industries.
 Salary: of these jobs depends upon Skills, experience in the position and type, of course, you studied like a diploma or degree so on.. A well versed experienced person in this field gets up to 10-14 lakhs per year or annum.

8)Clinical research : 

It is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, or for relieving symptoms of a disease.
So the duration of this course is six months for the certification course and one-year pg diploma course, and also, there is an MSc in Clinical research that is two years of duration.
Job: available as a Clinical research Analyst, Clinical Research Associates, Clinical Research Coordinator, Clinical Research Physicians, Biostatistician.
The average salary is about two and a half lakh to 5lakh.


9) Medicinal chemistry :

 Many of you pharmacy graduates or students know about this as a subject, so this Medicinal Chemistry program covers the dynamic areas of interest, which includes knowledge about drug discovery, product chemistry, organic synthesis, and much more. The course consists of topics surrounding the study of chemical bonding, chemical kinetics, synthetic organic chemistry, Thermodynamics, and others.
This course duration is three months for certification and also has Msc in medicinal chemistry with a duration of 2 years.
Then jobs here are mainly as an associate researcher and assistant professor. Also, in clinical research fields.
So guys here we go with the last course that is

10) Biostatistics or Pharmaceutical statistics

Biostatistics covers applications and contributions not only from health, medicines and, nutrition but also from fields such as genetics, biology, epidemiology, and many others. O It mainly consists of various steps like the generation of hypothesis, collection of data, and application of statistical analysis.
Duration in, pg diploma in biostatistics takes one year, and about certificate courses, you will find hardly very few institutions offer certificate courses in biostatistics.
Jobs available areas biostatistician in industries, clinical research companies, and in a few other sectors.
So the average salary of biostatisticians in India is 5 lakh approximately And variable Depending on the type of job and experience.
So, guys, these all are the courses I enlisted for You all my Pharmacy friends. These improve the quality of your resumes, in some cases, especially in Pharmaceutical industries. However, if you get a job thereby directly on your Graduate certificate and your Interview skills, while on your career, those industries may offer you to study free without Making you pay fees or those companies like Sun Pharma, IQVIA and some others pay your short term courses fees. So I also want you people to be motivated all the time and keep hardworking that gives excellent later on.

Work Hard in silence, and Make noise with Success. 

Kindly share this with your Pharmacy friends.

Click Here to know about career opportunities for Pharm.D


Saturday, July 25, 2020

In cell studies, seaweed extract outperforms remdesivir in blocking COVID-19 virus

In a test of antiviral effectiveness against the virus that causes COVID-19, an extract from edible seaweeds substantially outperformed remdesivir, the current standard antiviral used to combat the disease. Heparin, a common blood thinner, and a heparin variant stripped of its anticoagulant properties, performed on par with remdesivir in inhibiting SARS-CoV-2 infection in mammalian cells. The research is the latest example of a decoy strategy researchers from the Center for Biotechnology and Interdisciplinary Studies (CBIS) at Rensselear Polytechnic Institute are developing against viruses like the novel coronavirus that spawned the current global health crisis.

The spike protein on the surface of SARS-CoV-2 latches onto the ACE-2 receptor, a molecule on the surface of human cells. Once secured, the virus inserts its own genetic material into the cell, hijacking the cellular machinery to produce replica viruses. But the virus could just as easily be persuaded to lock onto a decoy molecule that offers a similar fit. The neutralized virus would be trapped and eventually degrade naturally.
Previous research has shown this decoy technique works in trapping other viruses, including dengue, Zika, and influenza A.
"We're learning how to block viral infection, and that is knowledge we are going to need if we want to rapidly confront pandemics," said Jonathan Dordick, the lead researcher and a professor of chemical and biological engineering at Rensselaer Polytechnic Institute. "The reality is that we don't have great antivirals. To protect ourselves against future pandemics, we are going to need an arsenal of approaches that we can quickly adapt to emerging viruses."
The Cell Discovery paper tests antiviral activity in three variants of heparin (heparin, trisulfated heparin, and a non-anticoagulant low molecular weight heparin) and two fucoidans (RPI-27 and RPI-28) extracted from seaweed. All five compounds are long chains of sugar molecules known as sulfated polysaccharides, a structural conformation that the results of a binding study published earlier this month in Antiviral Research suggested as an effective decoy.
The researchers performed a dose response study known as an EC50 -- shorthand for the effective concentration of the compound that inhibits 50% of viral infectivity -- with each of the five compounds on mammalian cells. For the results of an EC50, which are given in a molar concentration, a lower value signals a more potent compound.
RPI-27 yielded an EC50 value of approximately 83 nanomolar, while a similar previously published and independent in vitro test of remdesivir on the same mammalian cells yielded an EC50 of 770 nanomolar. Heparin yielded an EC50 of 2.1 micromolar, or about one-third as active as remdesivir, and a non-anticoagulant analog of heparin yielded an EC50 of 5.0 micromolar, about one-fifth as active as remdesivir.
A separate test found no cellular toxicity in any of the compounds, even at the highest concentrations tested.
"What interests us is a new way of getting at infection," said Robert Linhardt, a Rensselaer professor of chemistry and chemical biology who is collaborating with Dordick to develop the decoy strategy. "The current thinking is that the COVID-19 infection starts in the nose, and either of these substances could be the basis for a nasal spray. If you could simply treat the infection early, or even treat before you have the infection, you would have a way of blocking it before it enters the body."
Dordick added that compounds from seaweed "could serve as a basis for an oral delivery approach to address potential gastrointestinal infection."
In studying SARS-CoV-2 sequencing data, Dordick and Linhardt recognized several motifs on the structure of the spike protein that promised a fit compatible with heparin, a result borne out in the binding study. The spike protein is heavily encrusted in glycans, an adaptation that protects it from human enzymes which could degrade it, and prepares it to bind with a specific receptor on the cell surface.
"It's a very complicated mechanism that we quite frankly don't know all the details about, but we're getting more information," said Dordick. "One thing that's become clear with this study is that the larger the molecule, the better the fit. The more successful compounds are the larger sulfated polysaccharides that offer a greater number of sites on the molecules to trap the virus."
Molecular modeling based on the binding study revealed sites on the spike protein where the heparin was able to interact, raising the prospects for similar sulfated polysaccharides.

Career Opportunities for Pharm D (Doctor of Pharmacy) or What after Pharm D


Career Opportunities after Pharm D (Doctor of Pharmacy) or What after Pharm D

Many people think about joining the

 

Career Opportunities after Pharm D

Here a list of top ten career opportunities after Doctor of Pharmacy;

 

1.Clinical Pharmacist after Pharm D: 

The idea of this degree is to provide the students with a status so different that they would get a chance to work as a pharmacist and a doctor. Clinical Pharmacists have the role of optimizing medication, disease prevention, and healthcare. Clinical pharmacists regulate the therapeutic use of drugs. This job profile repays heavily. Not only in India but countries like the US, Canada, the UK, and Australia, this job profile has a broad scope. Considering this point, there is a light for opting Doctor of Pharmacy. 

 

2.Clinical Research after Pharm D

In hospitals or clinical research organizations, Pharm.D graduates are required to perform different research activities to come up with new solutions. The candidates have different roles in the clinical research sector. 

 

3.Analytical Chemist after Pharm D

The analytical chemists study the chemical composition of any matter. It is yet another promising job option that can be unblocked with the help of a Pharm.D degree. To become suitable for the job, the students should be well versed in bioanalysis, forensic science, clinical analysis, and materials analysis. Primarily, the role of an analytical chemist is to study the composition and behavior of different substances. 

 

4.Quality control Officers after Pharm D:

In pharmaceutical companies, there is a post of quality control officer who ensures that every medicine of pharmaceutical products is being made as per the prescribed standards. After a Pharm D degree, the candidates can work as quality control officers in this promising job. 

 

 

5.Medical writer after Pharm D:

It is one of the most recompensing jobs in the field of Pharmacy. With a PharmD degree, the students are eligible to become one. The key roles of a medical writer include working in association with the doctors or personnel from pharmacovigilance, to prepare accurate and cost-effective scientific documents. Medical writers are much desired on the global field. Countries like the US, UK, Canada, etc., receive Pharm D graduates very well. Consequently, by knowing how the candidate exchange program works, the students can go abroad to study. 

 

 

6.Community Pharmacist after Pharm D:

Pharm.D graduates can work as a community pharmacist and play an vital role in uplifting the community health. The community pharmacists impart information about medical drugs and their usage to the people.

 

7.Pharmacovigilance Associate after Pharm D:

Pharm. D associates have different roles during the development and testing of new drugs. Pharmacovigilance associates are also desired by the clinical research organizations to test the adverse drug effects on different patients. In Pharmaceutical industries also, there are openings for Pharmacovigilance associates who keep a check on the safety of drugs being manufactured.

 

8.Pharmacoeconomics researcher after Pharm D

It is a discipline that combines the postulates of economics and Pharmacy. Under this study, the cost and effect of one therapeutic drug are compared to another drug. Their evaluations can be categorized as cost-effective and cost-utility.

 

 

9.Drug Inspector after Pharm D: 

Drug inspectors are responsible for licensing and regulating the use, distribution, and sales of drugs. To be a drug inspector, one needs to appear in the relative government exam.

 

10.Teachers/Professors after Pharm D:

For those seeking to join the academic front, Pharm.D can help them very well. After this degree, the candidates can work as teachers in Pharmacy or another related curriculum educational Institutes. The students can also explore the opportunities for further studies in India. 

 

 

              There are lot more Career Opportunities after Pharm D. Pharm D is full of options that have not been explored by many people. It is a very appealing postgraduate degree for those who aspire to pursue something other than degree and Engineering courses. PharmD builds a link between the students and a better, brighter tomorrow. You are believing and deciding that you want to stay in the field for the long term. The instance you choose Pharm D, you mark the initiation of your success story. You can choose your best suitable career after your Pharm.D.

Tuesday, July 21, 2020

“Senior Research Fellow” (SRF) at NIMHANS




Applications are invited from eligible candidates, for the post of  “Senior Research Fellow” (SRF) on contract basis for the ICMR funded project entitled “Cell-free therapeutic approach to Parkinson’s disease using exosomes of human dental pulp stem cells as drug delivery tool through intranasal route” – under the guidance of Dr. Indrani Datta, Associate Professor of Biophysics & Principal Investigator.

Post: Senior Research Fellow (SRF)

Essential Qualification : M.Pharm with a good academic record. or M.Sc degree in the field of regenerative medicine /biophysics/ physiology/ biochemistry.  Two years of hands-on research experience after Master degree is mandatory.

Desirable : Experience in animal model generation, tissue processing, molecular biology and biochemistry will be required.

Nature of Work : The project covers extensively on in vivo Parkinson’s disease model, biodistribution of exosomes isolated from DPSCs, protein and gene expression studies.

Maximum Age Limit : 28 Years

Emoluments Per Month : Rs.35,000/- + 24% HRA

Duration of the Project : 3 years Initial appointment will be made for a period of six months and will be extended further depending upon the performance of the candidate.

Eligible candidates fulfilling the criteria must email their applications, along with resume and age proof to indranidatta.biophysics@gmail.com. The candidates, who apply, should invariably mention the Notification No., Date of birth, email ID, Contact No. and Postal address, failing which the application will not be considered.

Eligible candidates will be shortlisted. Interview will be conducted via video conference call and the details will be communicated to the shortlisted candidates. The last date for receipt of filled in softcopy of the applications along with the relevant documents is 27.07.2020. Applications received later will not be entertained.

Note:
1. The candidate joining will be subject to the procedure of quarantine from time to time as per the notification of the Govt. of Karnataka.
2. The quarantine period of the candidate will not be considered for salary & it will be at the personal cost of the candidate. The candidate cannot claim Institutional accommodation for the Quarantine.

Sunday, July 19, 2020

Friday, July 17, 2020

How to choose top notch research work in 5th Pharm D

As far as my knowledge concern, Pharm D 5th year is one such critical stage where the students are supposed to do a project work on areas related to pharmacoepidemeology, Pharmacotherapeutics, Pharmacokietics, Clinical Pharmacy etc.,

The project can be of any type but the key factors to be noted are :



1.Would that be useful for us in building up our resume?

2. Can we learn skills like statistical analysis, result determination, thesis writing?

3. Is our project really show a change in the topic of our interest. If not at least can it cause a change in our level of knowledge?

The title you choose should satisfy all of the above qualities.


Coming to the topics of project, we can do something related to :


1. Comparative studies like between drugs/diseases/Age Vs disease etc.

2. Prescription analysis example compile N number of prescriptions related to your interested variable and start analyzing the results about QOL, Quality of therapy, outcome of treatment etc)

3. Pharmacokinetic studies like You are supposed to tie up with a CRO and collect data of drug trial on patients and analyse the results.

4.Survey based study ( simplest one, prepare a questionnaire of your topic interested and collect responses from patients/Health care providers and analyse the results)

5. Prevalence and incidence studies( choose topic of your interest and collect data from hospitals/community and perform the prevalence of the disease and possible factors)

6. Multi centered studies ( choose more than two hospitals and collect data for the same topic of your choice and analyse the results and determine the reasons behind differences in disease Incidence Rate and therapy outcome)

We have many more to do upon your interest and abilities.
Feel free to comment here for any specific research in case of further clarifications needed.

Defined daily dose


The DDD is the assumed average daily maintenance dose for a drug for its main indication in adults.

Expressed as DDDs per 1000 inhabitants per day, for chronically used drugs

It can be interpreted as the proportion of the population that may receive treatment with a particular medicine on any given day.

For use in hospital settings, the unit is expressed as DDDs per 100 bed-days (adjusted for occupancy rate); it suggests the proportion of inpatients that may receive a DDD.

For medicines that are used for short-term periods, such as antimicrobials, the unit is expressed as DDDs per inhabitant per year; this provides an estimate of the number of days for which each person is treated with a particular medication in a year.

The defined daily dose (DDD) methodology was developed in response to the need to convert and standardize readily available volume data from sales statistics or pharmacy inventory data into medically meaningful units, to make crude estimates of the number of persons exposed to a particular medicine or class of medicines.

The DDD methodology is useful for working with readily available gross drug statistics and is relatively easy and inexpensive to use. However, the DDD methodology should

be used and interpreted with caution. The DDD is not a recommended or a prescribed dose, but a technical unit of comparison; it is usually the result of literature review and available information on use in various countries.

Prescribed daily dose

The prescribed daily dose (PDD) is another unit, developed as a means to validate the DDDs. The PDD is the average daily dose prescribed, as obtained from a representative sample of prescriptions.

Not useful to estimate incidence and prevalence of drug use or to quantify or identify patients who receive doses lower or higher than those considered effective and safe.

Tuesday, July 14, 2020

Job Alert Pharmacovigilance Associate


Job Description

Rewarding career opportunity with one of the fastest growing organization, APCER Life Sciences.


Job Description:

Data Entry of ICSRs in APCER (ArisG, Argus etc.)/client's pharmacovigilance database duplicate check, entering source data in the database, MedDRA coding, narrative(s) writing, labelling of events, report scheduling (if applicable) & attachment of source document in database
Screening, evaluation and review of literature articles for identification of valid/potential ICSRs for processing
Receipt and evaluation of safety data exchange agreements (If applicable) for sharing and other obligations
Execution of organization's standard operating procedures
Management of compliance with the organization's standard operating procedures and regulatory requirements
Liaise effectively and maintain excellent relationship with the internal contacts
Maintain awareness of changes to/new regulations affecting pharmacovigilance activities
Communicate new or changed regulations to relevant members of the department in order to initiate any change in processes
Builds and maintains good relationships across functional units and company affiliates
Escalate critical calls to concerned managers/clients Remain up-to-date with the latest information on the assigned product(s)
To carry out necessary administrative duties required for the job
Other duties as assigned by management
Trains and mentors new employees in PVG (if required)
Generation and review of SOPs and WIs (if required)
Complies with applicable ISMS related procedures & policies


Key Competencies:

Self motivated
Good competence with therapeutic and medical terminology
Meticulous attention to detail client focused approach
Ability to follow instruction and deliver assigned tasks within agreed timelines
Aptitude to learn new skills and enhance pharmacovigilance knowledge


Key Skills:

Knowledge of European and ROW (if applicable) regulatory requirements
Good time and management skills
Strong interpersonal & communication skills
Basic knowledge of Microsoft Office/Applicable software


Qualification :
A graduate/post graduate degree in Pharmaceutical sciences/Life Sciences


Submit your CV today to be considered for role within our organization.


Industry : Pharma / Biotech / Clinical Research

Functional Area : Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role : Documentation/Medical Writing

Keyskills : PSUR, Periodic Safety Update Report, Pader, PBRER, Periodic Benefit Risk Evaluation Report, Periodic Adverse Drug Experience Report, Aggregate Report, PSR, Periodic Safety Report, ACO, DSUR
Education Qualification


UG : B.Sc-Any Specialization,BAMS-Any Specialization,BDS-Dentistry,B.Pharma-Pharmacy,BHMS-Any Specialization

PG : MDS-Any Specialization,MS/M.Sc(Science)-Any Specialization,M.Pharma-Pharmacy
Company Profile

APCER Life Sciences provides comprehensive drug safety/pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally.

We bring medicinal / scientific expertise through our healthcare professionals & physicians and address full pharmacovigilance requirements for North America, UK & Europe markets. Our clients benefit from our vast experience in regulatory submissions across 100+ countries and consultative approach towards audit /inspection readiness.

Our focus towards Patient safety and Risk profile management makes us the preferred choice for pharma companies who are looking for pre /post marketing compliance & reporting solutions.

We have scalable operations across five global offices which house more than 750 employees: Princeton, NJ, USA; London, UK; Germany, Wan Chai, Hong Kong, New Delhi and Ahmedabad

APCER Life Sciences is an equal opportunity employer that is committed to diversity and inclusion. At APCER Life Sciences, employment decisions are made regardless of race, colour, national or ethnic origin, religion, gender, sexual orientation, gender identity or expression, age, marital status, disability or other characteristics protected by law and selected candidates will be offered appropriate designation / CTC in line with overall selection criteria & individual competence required for the role

Monday, July 13, 2020

INDIAN CONGRESS OF PHARMACY PRACTICE 2020 & 4TH IACP CONVENTION

Indian Congress of Pharmacy Practice 2020 and the 4th IACP convention’ is scheduled as an ONLINE CONFERENCE on Saturday 1st and Sunday 2nd August 2020 with the theme ‘Pharmacy Practice and Beyond’.

The Indian Congress of Pharmacy Practice 2020 & 4th IACP Convention aims at advancing pharmacy practice & education and look ‘Beyond’ the traditional approaches and create new opportunities and pathways that will pave way for an ‘Action Plan’ that is dedicated to four domains of action

Pharmacoacademics - Strengthening academic and Institutional capacity

Careers and beyond - Employment embedded education

The emergence of a specialist pharmacists - Education & Competencies

Strategic Plan - A vision for pharmacy practice profession and education

Fees: 1000 Rupees ( Including GST)



DRUG UTILIZATION REVIEW



Drug utilization review (DUR) programs have been defined as “structured, ongoing initiatives that interpret patterns of drug use in relation to predetermined criteria, and attempt to prevent or minimize inappropriate prescribing.”
DUR programs differ from drug utilization studies, which are time-limited investigations that measure drug use, but do not necessarily assess appropriateness or attempt to change practice.
Recently, the use of clinical decision support within computerized prescriber order entry (CPOE) programs has risen dramatically. The use of such programs to improve prescribing can be considered a form of prospective DUR in which prescribers are the targets of interventions
Generally, the DUR process involves comparing actual behavior to explicit, prospectively established standards, referred to as criteria. For example, a commonly used criterion is that patients should not receive more than one non steroidal anti-inflammatory agent at any one time. Criteria have been developed to identify the following types of problems: drug–drug interactions, drug–disease interactions, drug–age interactions, drug–allergy interactions, use of too high or too low a dose, duplication of therapeutic class, excessive duration of therapy, obtaining prescription refills sooner or later than should be needed, failure to prescribe a known effective agent in patients with certain conditions, abuse of psychoactive medications, and use of a more costly agent when a less costly agent is available. After developing criteria, the next step in the DUR process is to measure adherence to explicit criteria by examining individual-level data. Instances in which medication use does not agree with criteria are called exceptions.
Next, interventions are implemented where appropriate, often following an implicit review. Although the general model for DUR does not require that practitioners be made aware of individual exceptions occurring in their patients (that is, interventions can be made based on aggregate rather than individual findings), this step usually involves alerting the physician and/or pharmacy of record as to the occurrence of the specific exception.

There are different settings in which the DUR model is applied.

Outpatient retrospective DUR programs use
computerized administrative data (i.e., pharmacy and medical claims data maintained for billing and other administrative purposes) to identify exceptions that are then reviewed by a physician or pharmacist, or by a committee of health professionals, and result in an intervention (e.g., a mailed alert letter to the physician). The alert letter typically describes the DUR program and the criterion, and provides literature references supporting the criterion and a patient profile demonstrating that the criterion was violated.



Meta Ananlysis


Meta –analysis is a method which can be used to combine the results of two or more studies. The first Meta –analysis performed by karlpearson in 1904
Meta –analysis may conveniently be defined as a quantitative method of pooling information from independent studies concerning a single theme in order to draw conclusion.

Meta –analysis does not simply involve averaging the results of the individual studies, but requires a statistical method which combines the result whilst taking into account the size of the studies. Thus Meta –analysis is the statistical analysis of a large collection of analysis results for the purpose of integrating the findings.

Meta –analysis can provide researchers with single pooled results to answer whether treatment A is more beneficial than treatment B. This pooled result is usually more precise than the result from the individual studies. The precision with each of these studies calculates the treatment effect depends on many factors including the number of people in the study. Generally as the number of people increases in a study the precision of the treatment effect will increase.

Therefore by statistical combining the all the sample size together from the individual studies, the precision of our pooled result for the treatment effect can be improved.

Meta – analysis increases power. By combining the results from the smaller studies using Meta– analysis we can increase the overall power of the analysis. Therefore, the results from a Meta – analysis will usually have more power than the results from the individual studies.

STEPS TO PERFORM META – ANALYSIS

The theoretical  relationship of interest
Collect the population of studies that provide data on the relationship.
Code the studies and compute the effect sizes
Examine the distribution of effect sizes and analyze the impact of moderating variables
Interpret and report the results.

SUMMARY
 Meta – analysis leads to a shift of emphasis from single studies to multiple studies. It is performed with assistance of computer data bases (Microsoft access, paradox) and statistical software (DSTAT, SAS). The most common use of Meta – analysis has been in quantitative literature review. A valid meta – analysis however, require careful planning in the protocol stage as for any other research.

PHARMACOEPIDEMIOLOGIC STUDY DESIGNS


Pharmacoepidemiology
Ø Pharmacoepidemiology applies the methods of epidemiology to the content area of clinical pharmacology.
EPIDEMIOLOGIC STUDY DESIGNS:

CASE REPORTS

Case reports are simply reports of events observed in single patients. As used in Pharmacoepidemiology, a case report describes a single patient who was exposed to a drug and experiences a particular, usually adverse, outcome.

For example, one might see a published case report about a young woman who was taking oral contraceptives and who suffered a pulmonary embolism.

Case reports are useful for raising hypotheses about drug effects, to be tested with more rigorous study designs. However, in a case report one cannot know if the patient reported is either typical of those with the exposure or typical of those with the disease.

Certainly, one cannot usually determine whether the adverse outcome was due to the drug exposure or would have happened anyway. As such, it is very rare that a case report can be used to make a statement about causation.

One exception to this would be when the outcome is so rare and so characteristic of the exposure that one knows that it was likely to be due to the exposure, even if the history of exposure were unclear.

 An example of this is clear cell vaginal adenocarcinoma occurring in young women exposed inutero to diethylstilbestrol. Another exception would be when the disease course is very predictable and the treatment causes a clearly apparent change in this disease course.An example would be the ability of penicillin to cure streptococcal endocarditis, a disease that is nearly uniformly fatal in the absence of treatment. Case reports can be particularly useful to document causation when the treatment causes a change in disease course which is reversible, such that the patient returns to his or her untreated state when the exposure is withdrawn, can be treated again, and when the change returns upon repeat treatment. Consider a patient who is suffering from an overdose of methadone (a long-acting narcotic) and is comatose. If this patient is then treated with naloxone (a narcotic antagonist) and immediately awakens,this would be very suggestive that the drug indeed is efficacious as a narcotic antagonist. As the naloxone wears off the patient would become comatose again, and then if he or she were given another dose of naloxone the patient would awaken again. This, especially if repeated a few times,would represent strong evidence that the drug is indeed
effective as a narcotic antagonist. This type of challenge–re challenge situation is relatively uncommon, however, as physicians generally will avoid exposing a patient to a drug if the patient experienced an adverse reaction to it in the past.

CASE SERIES

Case series are collections of patients, all of whom have a single exposure, whose clinical outcomes are then evaluated and described.

Often they are from a single hospital or medical practice. Alternatively, case series can be collections of patients with a single outcome, looking at their antecedent exposures. For example, one might observe 100 consecutive women under the age of 50 who suffer from a pulmonary embolism, and note that 30 of them had been taking oral contraceptives.

After drug marketing, case series are most useful for two related purposes.
They can be useful for quantifying the incidence of an adverse reaction.
They can be useful for being certain that any particular adverse effect of concern does not occur when observed in a population which is larger than that studied prior to drug marketing.The so-called “Phase IV” post marketing surveillance study of prazosin was conducted for the former reason, to quantitate the incidence of first-dose syncope from prazosin. The“Phase IV” post marketing surveillance study of cimetidine was conducted for the latter reason.
Metiamide was an H-2 blocker, which was withdrawn after marketing outside the US because it caused agranulocytosis. Since cimetidineis chemically related to metiamide there was a concern that cimetidine might also cause agranulocytosis. In both examples, the manufacturer asked its sales representatives to recruit physicians to participate in the study. Each participating physician then enrolled the next series of patients for whom the drug was prescribed.
In this type of study, one can be more certain that the patients are probably typical of those with the exposure or with the disease, depending on the focus of the study.

However, in the absence of a control group, one cannot be certain which features in the description of the patients are unique to the exposure, or outcome. As an example,one might have a case series from a particular hospital of 100 individuals with a certain disease, and note that all were men over the age of 60. This might lead one to conclude that this disease seems to be associated with being a man over the age of 60.
 However, it would be clear that this would be an incorrect conclusion once one noted that the hospital this case series was drawn from was a Veterans Administration hospital, where most patients are men over the age of 60.

 In the previous example of pulmonary embolism and oral contraceptives, 30% of the women with pulmonary embolism had been using oral contraceptives.However, this information is not sufficient to determine whether this is higher, the same as, or even lower than would have been expected. For this reason, case series are also not very useful in determining causation, but provide clinical descriptions of a disease or of patients who receive an exposure.


CASE–CONTROL STUDIES

Case–control studies are studies that compare cases with a disease to controls  without the disease, looking for differences in antecedent exposures.

As an example, one could select cases of young women with venous thromboembolism and compare them to controls without venous thromboembolism, looking for differences in antecedent oral contraceptive use. Several such studies have been performed,generally demonstrating a strong association between the use of oral contraceptives and venous thromboembolism.

Case–control studies can be particularly useful when one wants to study multiple possible causes of a single disease,as one can use the same cases and controls to examine any number of exposures as potential risk factors.
This design is also particularly useful when one is studying a relatively rare disease, as it guarantees a sufficient number of cases with the disease.

 Using case–control studies, one can study rare diseases with markedly smaller sample sizes than those needed for cohort studies.

 For example, the classic study of diethylstilbestrol and clear cell vaginal adenocarcinoma required only 8 cases and 40 controls, rather than the many thousands of exposed subjects that would have been required for a cohort study of this question. Case–control studies generally obtain their information on exposures retrospectively, i.e., by recreating events that happened in the past. Information on past exposure to potential risk factors is generally obtained by abstracting medical records or by administering questionnaires or interviews.

As such, case–control studies are subject to limitations in the validity of retrospectively collected exposure information.In addition, the proper selection of controls can be a challenging task, and inappropriate control selection can lead to a selection bias, which may lead to incorrect conclusions.Nevertheless, when case–control studies are done well, subsequent well-done cohort studies or randomized clinical trials, if any, will generally confirm their results. As such, the case–control design is a very useful approach for pharmacoepidemiology studies.
Cross sectional studies
A cross sectional study measures the prevalence of health outcomes or determinants of health, or both, in a population at a point in time or over a short period.
They are usually done through surveys, chart reviews, or database analyses.
They provide a view of the state of affairs at that time, and provide an estimate of the prevalence of utilization and of outcomes.
Such information can be used to explore aetiology - for example, the relation between cataract and vitamin status has been examined in cross sectional surveys.
These types of studies have been used to compare drug use between countries or regions within a country. Very large differences suggest that reasons for those differences should be investigated and policies examined to determine whether outcomes and costs also differ and whether changes should be made.
However, associations must be interpreted with caution. Bias may arise because of selection into or out of the study population.
 A cross sectional survey of asthma in an occupational group of animal handlers would underestimate risk if the development of respiratory symptoms led people to seek alternative employment and therefore to be excluded from the study. A cross sectional design may also make it difficult to establish what is cause and what is effect.