Manager, Drug Safety & PV Operations

Manager, Drug Safety & PV Operations

Location:

Schedule:

Experience:

Roles

• Lead, develop, and mentor a team of PV professionals
• Act as the primary contact for drug safety queries across internal teams, distributors, affiliates, and authorities
• Steer decision-making related to PV operations, compliance, and safety risk management
• Oversee case management for both clinical and post-marketing safety
• Represent the PV function in cross-functional reviews related to patient safety, deviations, CAPA, and product quality

Responsibilities

• Ensure alignment with FDA, EMA, ICH, and regional safety regulations
• Oversee timely case intake, assessment, and processing of AEs
• Escalate potential safety issues to Global Pharmacovigilance
• Direct literature surveillance activities and identification of reportable cases
• Lead audits and manage inspection readiness
• Deliver PV and regulatory training to build team capability
• Track compliance KPIs and communicate performance insights
• Drive process improvements to enhance PV systems and workflows
• Support Health Hazard Evaluations and CAPA activities
• Foster strong collaboration across internal and external stakeholders

Qualifications

• 6–8 years of clinical/healthcare or safety-related experience
• 2–4 years of hands-on pharmacovigilance exposure (clinical or post-marketing)
• 4–6 years of team management experience
• Solid understanding of FDA/ICH safety reporting requirements
• Strong communication, analytical, and leadership skills
• Bachelor’s or Master’s in Pharmacy, Nursing, or Life Sciences (PV experience preferred)