Responsibilities

The Safety Operations Manager will oversee operational delivery and staff within Global Patient Safety (GPS) Operations, coordinating with safety vendors and GPS teams regarding case triage and processing, and expedited/aggregate reporting. They will collaborate with internal and external parties regarding safety-related deliverables and processes, including PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA). The role involves overseeing the assignment of Safety Specialist tasks, proactively identifying issues and areas for improvement, developing new processes and procedures, and implementing them. The manager will communicate within clients and business partners regarding deliverables, perform activities in compliance with client Controlled Procedures and applicable regulations, and perform other tasks as assigned by the line manager or Head of GPS. Advanced communication in written and spoken Japanese is required.