PMS Planning & Management Head候補/外資系製薬メーカー

求人詳細

■About the Job
As PMS Planning and Management Head within our Regulatory Affairs & Patient Safety team, you'll lead a high-performing group responsible for shaping post-marketing surveillance strategy, driving regulatory excellence, and ensuring the safety of patients who depend on our medicines. Ready to get started?
Ready to push the limits of what's possible? Join XXX in a senior leadership role at the heart of our regulatory and patient safety mission — where your strategic vision and scientific expertise will directly influence how we protect patients and engage with regulatory authorities in Japan and beyond. In this role, you'll lead a dedicated team, champion innovation in post-marketing surveillance, and play a pivotal part in the performance of our entire medicines portfolio.

■Main Responsibilities
• Lead and develop a high-performing team — build a strong, agile group grounded in strategic and scientific thinking, empowered to plan, execute, and report on post-marketing surveillance (PMS) activities with excellence and without being constrained by conventional approaches.

• Drive PMS strategy and planning — design and oversee scientifically appropriate PMS programs (including usage surveys, database studies, and post-marketing clinical trials) tailored to each product's profile, drawing on clinical trial data, global risk management practices, and regulatory commitments.

• Own regulatory authority engagement — lead negotiations with regulatory authorities, respond to inquiries, manage re-examination application conformity inspections, and represent the team in regulatory consultations with confidence and scientific rigor.

• Oversee the full PMS lifecycle — guide the team through study outline development, protocol and case report form creation, global approval processes, analysis plan formulation, CSR preparation, and periodic safety reporting.

• Champion cross-functional collaboration — build and sustain strong partnerships with Development, Medical, Safety, Regulatory Affairs, and Commercial teams — including global stakeholders — to ensure aligned, timely, and compliant PMS execution.

• Develop talent and shape the future of the function — mentor and grow team members, foster a culture of continuous improvement, and drive modernization of processes in line with evolving regulations and the external environment.

こんな方を求めています

経験・スキル

【Must要件】
・PMSに関する5年以上の経験
‐PMSの企画から実施、結果報告までを一貫してリードした実績がある方
・ビジネスレベルの英語力（ビジネスレベルの会話力）

【Want要件】
・データベース研究経験
・ピープルマネジメント経験

学歴

大学卒業以上

募集要項

職種

マーケティング、調査、マーケティングコミュニケーション、広報(PR)

給与

年収 1,000 〜 1,650万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り

就業時間

08:45～17:30

休日休暇

日曜日,土曜日,祝日
【休日メモ】完全週休2日制（土・日）、祝日、年末年始（12/29～1/4）、 【休暇メモ】フレキシブル休日、5/1、年次有給休暇、慶弔休暇 他

諸手当

【待遇・福利厚生メモ】各種社会保険完備、社宅制度、退職金制度、財形貯蓄制度、共済会　等

保険

健康保険,厚生年金保険,雇用保険,労災保険

待遇・福利厚生

【待遇・福利厚生メモ】各種社会保険完備、社宅制度、退職金制度、財形貯蓄制度、共済会　等

受動喫煙防止措置

敷地内禁煙

特長

外資系企業, 土日祝休み, 完全週休2日制, 年間休日120日以上

業種

医療機器・医療品関連

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更新日：2026/10/15