Apcer Life Sciences, a leading global life sciences and pharmacovigilance services organization, is currently hiring Pharmacovigilance Associates for its Ahmedabad location. This is an excellent opportunity for professionals with 2โ5 years of experience in Pharmacovigilance (PV), particularly in ICSR processing, safety data entry, medical coding, and regulatory compliance.
Candidates with a strong understanding of global pharmacovigilance guidelines, safety databases, and adverse event reporting will find this role well aligned with their career growth in drug safety and regulatory sciences.
๐ Job Overview
- Position: Pharmacovigilance Associate
- Company: Apcer Life Sciences
- Location: Ahmedabad, Gujarat
- Experience Required: 2โ5 years
- Employment Type: Full-time, Permanent
- Openings: 5
- Industry: Pharmaceutical & Life Sciences
๐งพ Key Responsibilities
As a Pharmacovigilance Associate, you will be responsible for end-to-end ICSR lifecycle management and PV compliance activities, including:
- Data entry of Individual Case Safety Reports (ICSRs) into pharmacovigilance databases
- Case booking and triaging of ICSRs
- Medical coding (MedDRA, WHO-DD) and narrative writing
- Generation of follow-up letters to reporters
- Review of scientific and medical literature to identify valid ICSRs
- Performing quality checks (QC) on safety cases
- Supporting preparation of aggregate safety reports (PSUR, PBRER, DSUR โ if applicable)
- Assisting in signal detection and ADR trend analysis
- Ensuring compliance with SOPs, project guidelines, and global PV regulations
- Staying updated with regulatory changes impacting pharmacovigilance activities
- Coordinating with cross-functional and affiliate teams
๐ Qualifications & Skills Required
Educational Qualifications
- UG: B.Pharm (Any Specialization)
- PG: M.Pharm (Any Specialization)
Key Skills
- Pharmacovigilance & Drug Safety Operations
- ICSR processing and safety data entry
- MedDRA and WHO-DD coding
- Narrative writing and case quality review
- Knowledge of global PV regulations (ICH, GVP, FDA, EMA)
- Excellent written and verbal communication skills
๐ผ Why Join Apcer Life Sciences?
- Work with a globally recognized PV and regulatory services company
- Exposure to international pharmacovigilance projects
- Strong focus on quality, compliance, and career development
- Professional work environment with long-term growth opportunities
๐ฐ Salary & Compensation
- Estimated Salary Range: โน4,00,000 โ โน7,00,000 per annum (INR)
- Salary is commensurate with experience and skill set
๐ How to Apply
