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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.

応募資格・募集要項・仕事内容を見る

応募資格

必須

Minimum 7–10 years of pharmacovigilance experience in the pharmaceutical industry, including significant exposure to Japan PV regulations (J‑GVP, GPSP).
Demonstrated experience interacting with PMDA and supporting regulatory inspections.
Strong understanding of global PV regulations (ICH, GVP) and how they interface with Japan requirements.
Safety Database experience (such as Argus-J)
Proven ability to operate effectively in a matrixed, global organization, with strong cross‑functional and cross‑regional communication skills.
Excellent written and verbal communication skills in Japanese and English.
Strong leadership, problem‑solving, and decision‑making capabilities.

歓迎

People‑management experience, including the ability to mentor, develop, and motivate team members, is preferred.

募集要項最終確認 11/5

職種: 臨床開発・薬事
雇用形態: 記載なし
役職: Director
給与: 記載なし
勤務地: Minato, Tokyo, Japan, 108-0074
働き方: 記載なし
経験年数: 7年以上
掲載日: 2026/10/13 06:27（23日前）
最終確認: 2026/11/05 01:18（今日）

仕事内容

Job Description Summary

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.

Key Responsibilities

Serve as the Anseki (Safety Management Supervisor) in accordance with J‑GVP, ensuring full compliance with Japan PV regulatory requirements.
Act as a primary point of contact for PMDA and MHLW on safety‑related matters, including inquiries, inspections, and post‑marketing safety commitments.
Ensure timely and accurate expedited ICSR reporting, periodic safety reporting, risk management plan (RMP/J‑RMP) development, and safety‑related labeling updates.
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).
Oversee local literature surveillance, safety data review, and compliance with all Japan‑specific reporting requirements.
Ensure a comprehensive PV training program for all relevant staff in Japan
Lead inspection readiness activities and manage PMDA inspections, internal audits, and vendor audits, including CAPA development and follow‑up.
Develop, maintain, and update SOPs, work instructions, and controlled documents related to post‑marketing safety activities.
Monitor evolving PV regulations and proactively communicate requirements and impact assessments to internal stakeholders.
Partner with senior leaders in PV, Medical Affairs, Regulatory Affairs, Quality, and Commercial to ensure aligned safety strategies across the product lifecycle.
Collaborate with global PV teams to ensure consistency of processes, alignment with global safety strategy, and effective implementation of global systems and tools.
Support cross‑functional initiatives such as labeling updates, post‑marketing studies, and safety governance meetings.
Manage and oversee local vendors performing PV activities, ensuring compliance with contractual obligations, KPIs, and quality standards.
Ensure appropriate oversight of distributors, partners, and third parties who may receive safety information.
Lead, mentor, and develop Japan‑based PV team members, ensuring clear role expectations, effective performance management, and continued professional growth.

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