Manager - Pharmacovigilance & Safety Monitoring

Manager - Pharmacovigilance & Safety Monitoring

Responsibilities:

- 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 documentation.

Qualifications & 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.