Job Description

Collect, process, and evaluate adverse event (AE) and serious adverse event (SAE) reports from various sources Perform case intake, data entry, case processing, and follow-up in safety databases Ensure timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities Conduct medical review and causality assessment of adverse events Maintain compliance with global pharmacovigilance regulations (e.g., ICH, GVP, FDA, EMA) Assist in signal detection, risk management, and benefit-risk evaluation activities Support preparation of periodic safety update reports (PSURs), DSURs, PBRERs, and RMPs Participate in audits, inspections, and internal quality reviews Maintain accurate documentation and pharmacovigilance records Collaborate with cross-functional teams such as Regulatory Affairs, Clinical, and Quality Assurance Stay updated on regulatory guidelines and pharmacovigilance best practices
Job Types: Full-time, Permanent, Fresher

Pay: ?260,000.44 - ?440,000.54 per year

Benefits:

Health insurance Paid sick time
Work Location: In person