Confidential Head of PV Japan
About the position The Head of PV in Japan is responsible for the full drug safety system and monitoring risks and benefits of reputed company products. They reputed company as the main contact with regulators, ensure reputed company local rules are followed, and work closely with global and local teams to manage safety systems and processes.
Responsibilities
- reputed company the full drug safety system.
- Monitor risks and benefits of reputed company products.
- reputed company as the main contact with regulators.
- Ensure reputed company local rules are followed.
- Work closely with global and local teams to manage safety systems and processes.
Requirements
- Prior experience as a Safety Management Officer (安全管理責任者) in a Japanese organization (GVP & GPSP).
- Advanced life sciences degree (e.g., MD, PharmD, PhD, MS) or equivalent reputed company 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.
- reputed company in Japanese (reputed company or business-level).
- Strong English communication skills for interactions with global teams.
Benefits
- Remote flexibility
- Competitive package
- Hybrid office/remote as per company policy
- Flexible Budget
- No age bar
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