Monitors drug safety and adverse event reporting for marketed and pipeline products.
Process Individual Case Safety Reports (ICSRs) Submit safety reports to regulatory authorities Maintain safety databases (Argus, ARISg) Perform signal detection and risk assessment Prepare PSURs and RMPs
B.Pharm / M.Pharm / MBBS / Life Sciences 1–5 years in pharmacovigilance Knowledge of ICH E2A–E2F guidelines Experience with safety databases preferred
Mandatory Skills
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