Pharmacovigilance (pv) Director, Japan

GE HealthCare UK

Tokyo, Japan
Japan pv regulatory requirements
Anseki role
Pmda and mhlw liaison
This senior leadership role ensures the safe and compliant commercialization of pharmaceutical products in Japan, providing strategic oversight of all Japan PV activities

Job Summary

  • This senior leadership role ensures the safe and compliant commercialization of pharmaceutical products in Japan, providing strategic oversight of all Japan PV activities.
  • Key responsibilities include serving as the Anseki, acting as the primary point of contact for PMDA and MHLW, and ensuring timely reporting and robust PV system maintenance.
  • The company offers a culture that fosters care, collaboration, and support, with opportunities for professional growth and a focus on turning ideas into world-changing realities.

Matching Summary

This senior leadership role ensures the safe and compliant commercialization of pharmaceutical products in Japan, providing strategic oversight of all Japan PV activities.

Skills & Requirements

Must-have

  • Japan PV regulatory requirements
  • Anseki role
  • PMDA and MHLW liaison
  • Expedited ICSR reporting
  • Risk Management Plan development
  • PV system oversight

Nice-to-have

  • Global PV strategy alignment
  • Cross-functional collaboration
  • Team leadership and development
  • Operational excellence
  • Continuous improvement

Key Requirements

  • 7-10 years pharmacovigilance experience
  • Significant Japan PV regulations exposure
  • Experience interacting with PMDA
  • Strong understanding of global PV regulations
  • Safety Database experience
  • Excellent Japanese and English communication

Work Rights

Not specified

Tailored Resume

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