This person is accountable for developing, implementing, and executing a comprehensive risk-based Pharmacovigilance Quality Program, including strategic audit planning, internal and external audits, vendor qualification and oversight, health authority inspection readiness, quality investigations, CAPA management, quality metrics, compliance monitoring, and governance activities. Audit activities may include evaluation of case processing and reporting compliance, signal management programs, safety governance processes, safety databases, aggregate reporting activities, REMS operational controls, REMS vendor performance, quality systems, and business partner compliance activities.