Pharmacovigilance (PV) Director, Japan
Core
Senior leadership role ensuring safe and compliant commercialization of pharmaceutical products in Japan, serving as the Anseki (Safety Management Supervisor) and primary interface with PMDA.
Role type
Senior IC Pharmacovigilance Director (Japan)
Builds
Robust, inspection-ready PV system for detection, collection, processing, evaluation, and reporting of adverse events in Japan.
Domain
Pharmaceutical industry + Pharmacovigilance (Japan regulatory domain)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Japan PV regulations (J-GVP, GPSP), PMDA interaction, expedited ICSR reporting, periodic safety reporting, risk management plan development, safety database management, local literature surveillance, SOP development, vendor management, team leadership
Preferred skills
Global PV regulations (ICH, GVP), matrixed organization experience, cross-functional collaboration, post-marketing studies, safety governance
Technologies
Argus-J
Responsibilities
Serve as Anseki ensuring compliance with J-GVP; Act as primary contact for PMDA/MHLW on safety matters; Ensure timely ICSR and periodic safety reporting; Establish and maintain PV system for adverse event processing; Oversee local literature surveillance and reporting; Lead inspection readiness and manage PMDA inspections; Develop and update SOPs; Monitor evolving regulations; Partner with global and cross-functional teams; Manage local PV vendors; Lead and mentor Japan-based PV team
Seniority
Senior, hands-on IC with strategic oversight
