Job description
Role: Head of Pharmacovigilance (PV) Team: Managing 5–6 direct reports Workstyle: Remote flexibility with a competitive package The key requirements for this job are:
- Prior experience as a Safety Management Officer（安全管理責任者） in a Japanese organization (GVP & GPSP)
- Strong English communication skills for interactions with global teams The Head of PV in Japan is responsible for the full drug safety system and monitoring risks and benefits of all products. They act as the main contact with regulators, ensure all local rules are followed, and work closely with global and local teams to manage safety systems and processes.
Requirements
Advanced life sciences degree (e.g., MD, PharmD, PhD, MS) or equivalent healthcare qualification. 8–12+ years of PV/drug safety experience with substantial Japan GVP/GPSP execution; prior leadership of affiliate PV operations. Demonstrated authority interaction experience (e.g., PMDA inspections, safety responses, labeling negotiations).
Strong knowledge of PMDA submission standards, RMP, signal management, aggregate reporting, and PMS under GPSP. Fluency in Japanese (native or business‑level) and strong English communication skills.
Benefits
Hybrid office/remote as per company policy Flexible Budget and No age bar