Pharmacovigilance QA Manager

Job Summary

A company is looking for a Manager, Pharmacovigilance QA.

Key Responsibilities

• Provide quality assurance oversight for Pharmacovigilance (PV) and Device Vigilance (DV) activities to ensure regulatory compliance
• Support quality and compliance improvement initiatives and develop strategies in collaboration with business partners
• Assist with Health Authority inspections and guide the development of corrective and preventative action plans (CAPA)

Required Qualifications

• A minimum of two years of experience in pharmacovigilance quality or related pharmaceutical industry roles
• Experience with PV auditing, inspection, and Health Authority interactions is a plus
• Knowledge of PV regulations, guidelines, and Quality Management Systems
• Ability to manage compliance issues with limited supervision
• Experience operating cross-functionally in diverse cultural environments