Confidential Head of PV Japan
Posted Updated
- 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:
1. Prior experience as a Safety Management Officer（安全管理責任者） in a Japanese organization (GVP & GPSP)
2. 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