Director, Head of PV and REMS Compliance

Role: Lead global Patient Safety (PV) quality and compliance, ensuring adherence to GVP regulations and inspectorate standards. Responsibilities: oversee PV quality governance, monitor safety outputs, evaluate and mitigate compliance risks, and lead US REMS programs, inspections, and audit readiness; drive quality improvements using innovative technology; act as a senior strategic partner across PV, R&D, Regulatory, and IT functions; develop high-performing teams. Requirements: Bachelor's degree with strong scientific background; approximately 10 years in pharmacovigilance or related disciplines; 7+ years in leadership roles. HighValue: pharmacovigilance, patient safety, global GVP compliance, US REMS programs, risk-based monitoring, inspection readiness, digital transformation in PV, cross-functional collaboration. WorkSetup: hybrid, with 5-10% travel for site visits and inspections.