Pharmacovigilance (pv) Director, Japan

GE HealthCare

Japan pv regulatory requirements
Pmda and mhlw interface
Expedited icsr reporting
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

Job Summary

  • 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.
  • The Director leads Japan’s PV system, manages and develops the Japan PV team, collaborates closely with global safety teams, and drives operational excellence across post marketing safety activities.
  • GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits.

Matching Summary

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.

Skills & Requirements

Must-have

  • Japan PV regulatory requirements
  • PMDA and MHLW interface
  • Expedited ICSR reporting
  • Robust PV system
  • Local literature surveillance
  • PV training program
  • Inspection readiness
  • SOP development and maintenance
  • Global PV team collaboration
  • Vendor oversight

Nice-to-have

  • Operational excellence
  • Team development
  • Cross-functional initiatives
  • Unwavering integrity

Key Requirements

  • 7-10 years pharmacovigilance experience
  • Significant Japan PV regulations exposure
  • Experience interacting with PMDA
  • Experience supporting regulatory inspections
  • Strong understanding of global PV regulations
  • Safety Database experience (e.g., Argus-J)
  • Experience in a global organization
  • Excellent Japanese and English communication

Work Rights

Not specified

Tailored Resume

Cover Letter