Manager, Clinical Quality - Pharmacovigilance

Role: Lead the global Pharmacovigilance Quality System development, implementation, and continuous improvement, supporting both clinical and post-marketing safety activities. Responsibilities: Provide independent oversight of pharmacovigilance processes, systems, vendors, and REMS programs; conduct risk-based audits and assessments of PV systems, vendors, and affiliates; lead inspection readiness initiatives; evaluate compliance with GVP, FDA, EMA, and ICH regulations; oversee CAPAs, deviations, investigations, and quality metrics; and support regulatory authority inspections. Qualifications: Minimum 8 years in pharmaceutical/biotech/CRO with expertise in Pharmacovigilance Quality, REMS, Drug Safety, or Compliance; Bachelor's degree required; experience leading global PV quality programs and supporting inspections highly preferred. High-Value: Focus on pharmacovigilance (adverse event processing, signal detection, aggregate safety reports), REMS oversight (ETASU, patient enrollment, reporting), vendor qualification, audit strategy, inspection readiness, and quality systems. Work setup: Not specified; role involves cross-functional collaboration with Drug Safety, Medical Affairs, Regulatory, and external vendors.