About this role

<h1>Job Description Summary</h1>The Pharmacovigilance (PV) Director & Anseki is a senior leadership role required under the Japanese Pharmaceutical and Medical Device Act (PMD Act) to ensure the 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. 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. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.<h1>Job Description</h1>Key Responsibilities<ul><li>Serve as the Anseki (Safety Management Supervisor) in accordance with J‑GVP, ensuring full compliance with Japan PV regulatory requirements.</li><li>Act as a primary point of contact for PMDA and MHLW on safety‑related matters, including inquiries, inspections, and post‑marketing safety commitments.</li><li>Ensure timely and accurate expedited ICSR reporting, periodic safety reporting, risk management plan (RMP/J‑RMP) development, and safety‑related labeling updates.</li></ul><ul><li>Establish, maintain, and continuously improve a robust and inspection‑ready PV system that enables detection, collection, processing, evaluation, and reporting of adverse events (using safety database and other related tools).</li><li>Oversee local literature surveillance, safety data review,

Apply for this role on GE HEALTHCARE’s official careers site.

Pharmacovigilance (PV) Director, Japan

About this role

Similar jobs