Senior Director, Global Patient Safety Quality and Compliance

Role: Senior Director of Global Patient Safety Operations, leading pharmacovigilance activities for a biopharma focused on RAS-addicted cancers, with an emphasis on scalable, compliant safety systems and processes. Responsibilities: oversee case processing, vendor governance, safety database management, aggregate reporting, and inspection readiness; develop leadership and ensure cross-functional collaboration across clinical, regulatory, and quality teams; support safety reporting and compliance for global markets including US and EU; lead audits and inspections; serve as an operational advisor. Requirements: bachelor’s degree (advanced degree preferred), 10–12+ years in drug safety or pharmacovigilance, extensive experience in global safety operations, vendor management, and regulatory compliance; in-depth knowledge of FDA, EMA, ICH guidelines; proven leadership in managing teams and complex programs; strong strategic, operational, and communication skills. HighValue: oncology, RAS-targeted therapies, pharmacovigilance, global safety databases, regulatory inspections, vendor oversight, cross-disciplinary stakeholder management. WorkSetup: not specified, likely corporate headquarters; travel requirements not detailed.