Associate Medical Safety Director

IQVIA

Tokyo, Japan
Medical review of adverse events
Aggregate safety data review
Medical oversight for label development
This position is a leadership role responsible for managing the Japanese team, reporting globally, and providing medical advice on clinical trial and post-marketing safety

Job Summary

  • This position is a leadership role responsible for managing the Japanese team, reporting globally, and providing medical advice on clinical trial and post-marketing safety.
  • Key responsibilities include medical review of adverse events, literature evaluation, research measure evaluation, and providing medical support for various regulatory reports and risk management plans.
  • The role involves working with antibody drugs and biologics, particularly in oncology and orphan disease areas, and requires business-level English and Japanese proficiency.

Matching Summary

This position is a leadership role responsible for managing the Japanese team, reporting globally, and providing medical advice on clinical trial and post-marketing safety.

Skills & Requirements

Must-have

  • Medical review of adverse events
  • Aggregate safety data review
  • Medical oversight for label development
  • Protocol and IDB safety review
  • Business-level English and Japanese

Nice-to-have

  • Adaptability in remote environment
  • Experience in CRO or manufacturer
  • Leadership and management skills

Key Requirements

  • Japanese physician license
  • Three years of clinical practice experience
  • Two additional years in pharmaceutical industry
  • Knowledge of clinical research regulations
  • Business-level English proficiency
  • Business-level Japanese proficiency

Work Rights

Not specified

Tailored Resume

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