Pharmacovigilance (pv) Director, Japan

GEHC

Tokyo, Japan
Japan pv regulatory compliance
Pmda and mhlw liaison
Post-marketing safety activities
The Pharmacovigilance Director & Anseki is a senior leadership role required under the Japanese Pharmaceutical and Medical Device Act to ensure safe and compliant commercialization of pharmaceutical products in Japan

Job Summary

  • The Pharmacovigilance Director & Anseki is a senior leadership role required under the Japanese Pharmaceutical and Medical Device Act to ensure safe and compliant commercialization of pharmaceutical products in Japan.
  • This position provides strategic oversight of all Japan PV activities, ensures full compliance with J GVP, GPSP, and other applicable regulations, and serves as a key interface with PMDA.
  • GE HealthCare offers a culture that fosters care, collaboration, and support with total rewards designed to unlock ambition and provide career opportunities within a global organization.

Matching Summary

The Pharmacovigilance Director & Anseki is a senior leadership role required under the Japanese Pharmaceutical and Medical Device Act to ensure safe and compliant commercialization of pharmaceutical products in Japan.

Skills & Requirements

Must-have

  • Japan PV regulatory compliance
  • PMDA and MHLW liaison
  • Post-marketing safety activities
  • Safety database experience
  • PV team leadership
  • Inspection readiness management

Nice-to-have

  • Cross-functional collaboration
  • Global PV strategy alignment
  • Mentoring and team development
  • Strong communication skills
  • Problem-solving and decision-making

Key Requirements

  • 7–10 years pharmacovigilance experience
  • Significant exposure to Japan PV regulations
  • Experience interacting with PMDA
  • Safety database expertise (e.g., Argus-J)
  • Bilingual Japanese and English communication

Work Rights

Not specified

Tailored Resume

Cover Letter