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

Click here to apply https://apcerls.referralrecruit.com/referral/jobapply?jobId=100720000838&xid=34407320b8yuhL&utm_campaign=jobs_on_facebook&utm_medium=organic&utm_source=jobs_on_facebook