Pharmacovigilance (pv) Director, Japan

GE HealthCare Technologies

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Japanese pharmaceutical and medical device act compliance
Pmda and mhlw regulatory interaction
J-gvp and gpsp regulatory knowledge
** The Pharmacovigilance (PV) Director at GE HealthCare Technologies is a senior leadership role responsible for ensuring compliance with Japan's pharmaceutical regulations and overseeing the local PV team. The ideal candidate will have extensive experience in pharmacovigilance, a strong understanding of local regulations, and leadership capabilities. **

Job Summary

  • This senior leadership role serves as the Anseki under the Japanese PMD Act to ensure safe and compliant commercialization of pharmaceutical products.
  • The Director acts as the primary interface with PMDA and MHLW, managing inspections, inquiries, and post-marketing safety commitments.
  • GE HealthCare offers a culture that fosters care and collaboration while providing global strength and scale for career opportunities.

Matching Summary

Match Score: 75

** The Pharmacovigilance (PV) Director at GE HealthCare Technologies is a senior leadership role responsible for ensuring compliance with Japan's pharmaceutical regulations and overseeing the local PV team. The ideal candidate will have extensive experience in pharmacovigilance, a strong understanding of local regulations, and leadership capabilities. **

Skills & Requirements

Must-have

  • Japanese Pharmaceutical and Medical Device Act compliance
  • PMDA and MHLW regulatory interaction
  • J-GVP and GPSP regulatory knowledge
  • Safety database experience (Argus-J)
  • ICSR and periodic safety reporting management

Nice-to-have

  • Global PV team collaboration experience
  • Vendor management and oversight skills
  • Cross-functional leadership capabilities
  • Mentoring and team development focus
  • Strategic risk management planning

Key Requirements

  • 7-10 years pharmacovigilance experience in Japan
  • Demonstrated PMDA inspection support experience
  • Fluency in Japanese and English communication
  • Experience with Argus-J safety database
  • Leadership experience in matrixed organizations

Work Rights

Not specified

Tailored Resume

Cover Letter