Assistant Director/ Associate Director/ Director, Patient Safety Operations

Role: Lead Patient Safety Operations for clinical development and post-marketing phases, ensuring pharmacovigilance compliance and safety data integrity. Responsibilities: oversee case processing workflows, manage safety vendors, maintain audit readiness, develop SOPs, and support regulatory inspections; serve as safety SME on cross-functional teams; coordinate safety data exchange with partners; support vendor collaborations and product launches. Requirements: minimum 10 years in drug safety/pharmacovigilance; degree in life sciences or equivalent; proficiency in Argus, Veeva, eTMF, EDC; experience with inspections or audits; strong leadership and project management skills. HighValue: global PV regulations, safety data management, vendor oversight, inspections, cross-functional collaboration. WorkSetup: not specified; likely hybrid or on-site with international scope.