Director, Global Drug Safety & Pharmacovigilance Compliance

Role: Establish and lead US-based Pharmacovigilance (PV) Compliance to strengthen global PV oversight, support audits, inspections, and ensure regulatory adherence across development and post-marketing activities. Responsibilities: Develop and maintain PV policies, procedures, and workflows; oversee audit/inspection preparation, conduct, and responses; coordinate documentation and follow-up actions; manage quality events, compliance monitoring, and training; represent GDS&PV compliance in governance forums; support regional compliance in line with global regulations. Requirements: Advanced healthcare degree; 12+ years in PV/Clinical Research; extensive experience managing PV processes, audits, regulatory submissions, and safety data systems; strong knowledge of FDA, EMA, PMDA, ICH guidelines; proven leadership and stakeholder communication skills. Preferred: Experience mentoring teams and working across clinical development phases, from clinical through post-marketing. High-Value: Focus on global PV compliance with a US-specific oversight role, supporting GDS&PV's development and post-market activities, with an emphasis on audit readiness, regulatory adherence, and cross-functional collaboration. Work arrangement: Flexible work from 20-40% remote; specific location not specified; travel expectations not detailed.