Global Senior PV QA Manager

The Global Senior Pharmacovigilance QA Manager plays a key strategic role in ensuring the robustness, compliance, and continuous improvement of the global Pharmacovigilance (PV) Quality System. The position leads global PV audit activities, supports inspection readiness, and ensures harmonized PV processes across affiliates in alignment with international regulatory requirements.

Key Responsibilities

• Lead, plan, and execute global risk‑based PV QA audit programs (internal, external, vendor, affiliate).
• Ensure consistent implementation of PV Quality Systems across global affiliate sites.
• Act as PV QA liaison for affiliates, providing expert guidance, oversight, and strategic support.
• Manage audit reporting, tracking, trending, and CAPA effectiveness verification.
• Support and lead interactions with global Health Authorities during PV inspections; ensure inspection readiness.
• Monitor PV compliance issues and e...