Drug Safety Officer

Drug Safety Officers (Pharmacovigilance Officers) collect, assess, and report individual case safety reports (ICSRs) and aggregate safety data for medicinal products in compliance with EU GVP (Good Pharmacovigilance Practices) guidelines, ICH E2 guidelines, and national pharmacovigilance regulations. They perform benefit-risk assessments, manage signal detection processes, and liaise with EMA and national competent authorities on safety issues. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) and growing post-approval safety requirements drive consistent demand.