Manager - Pharmacovigilance & Safety Monitoring

Manager - Pharmacovigilance & Safety Monitoring Lead pharmacovigilance operations including adverse event (AE) reporting, signal detection, and risk assessment.

• Ensure timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities.
• Oversee global safety databases and compliance with PV regulations (USFDA, EMA, CDSCO).
• Collaborate with clinical, regulatory, and medical affairs teams for safety strategy and audits.
• Train and mentor PV associates; manage SOPs and safety & Skills :
• M.Pharm / MBBS / Life Sciences graduate with 6-10 years of experience.
• Strong knowledge of Argus, MedDRA coding, and global PV guidelines.
• Experience in handling regulatory inspections and safety narratives.
• Excellent analytical, communication, and documentation skills.

(ref : iimjobs.com)