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)
Required skills
Japan PV regulations (J-GVP, GPSP), PMDA interaction, Safety Database (Argus-J), SOP development, Vendor management, Team leadership, Regulatory inspections
Preferred skills
People management, Mentorship, Cross-functional collaboration
Technologies
Argus-J, Safety databases
Responsibilities
Serve as Anseki ensuring compliance with J-GVP; Act as primary contact for PMDA/MHLW; Ensure timely ICSR reporting and RMP development; Establish and maintain PV system for adverse event reporting; Lead inspection readiness and manage PMDA inspections; Develop and update SOPs; Partner with global PV teams; Manage local vendors and distributors; Lead and mentor Japan-based PV team.
Seniority
Director, strategic leadership & team management