Job Description

Perform case intake, processing, and data entry of adverse event (AE) reports in safety databases. Review source documents such as medical records, literature, or clinical reports for safety information. Code adverse events and drugs using MedDRA and WHO Drug Dictionary. Assess seriousness, expectedness, and causality of reported events. Prepare and submit Individual Case Safety Reports (ICSRs) to regulatory authorities within timelines. Support aggregate reporting (PBRERs, PSURs) and signal detection activities. Ensure compliance with global pharmacovigilance guidelines (ICH, EMA, FDA, CDSCO). Participate in quality checks and reconciliation of safety data. Assist in maintaining safety databases and document management systems. Support team in audits, inspections, and training activities.
Job Types: Full-time, Permanent, Fresher

Pay: ₹261,266.52 - ₹580,569.19 per year

Benefits:

Health insurance Paid sick time Provident Fund
Work Location: In person