Pharmacovigilance (PV) Manager

Job Purpose

The Pharmacovigilance (PV) Manager is responsible for managing end-to-end drug safety operations, ensuring compliance with global regulatory requirements, and leading a team of PV professionals to maintain high-quality safety surveillance and reporting for all products in the portfolio.

Key Responsibilities

• Oversee ICSR case processing and ensure timely, accurate submissions to health authorities (FDA, EMA, MHRA, etc.)

• Ensure adherence to global PV regulations and company SOPs

• Review and approve safety narratives, case QC, and reports

• Lead and mentor Drug Safety Associates, Specialists, and Team Leads

• Coordinate preparation and submission of aggregate reports (PSUR, PBRER, DSUR, RMP)

• Support signal detection, risk management, and benefit-risk evaluations

• Manage audits, inspections, and health authority queries

• Collaborate with Clinical, Regulatory, and Medical Affairs teams on safety-related activities

• Implement process improvements, maintain PV metrics, and ensure data integrity

Qualifications & Skills

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or Medicine

• 8–12 years of experience in Pharmacovigilance / Drug Safety

• Strong knowledge of global PV regulations (ICH, FDA, EMA, MHRA)

• Experience with safety databases (Argus, ArisG, Veeva Safety, or similar)

• Proven leadership, team management, and stakeholder communication skills

• Experience in audit preparation and regulatory inspections

Preferred

• Experience in global case processing (US, EU, ROW)

• Knowledge of signal management and risk evaluation

• Vendor management experience