PMS Planning & Management Specialist

Job title: PMS Planning and Management Specialist

• Location: Tokyo, Japan

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About the job

As a PMS Planning and Management Specialist within our Regulatory Affairs team, you'll help ensure the safety and integrity of new medicines by designing and managing scientifically rigorous post-marketing surveillance programs — playing a critical role in protecting patients and meeting Japan's highest regulatory standards. Ready to get started?

Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and play a vital part in the performance of our entire business while helping to make an impact on millions around the world. In this role, you'll sit at the intersection of science, regulation, and patient safety — collaborating across global teams to ensure that every medicine we bring to market continues to deliver on its promise, long after approval.

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About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

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Main responsibilities

• Design and plan scientifically appropriate post-marketing surveillance (PMS) programs — including usage status studies, database studies, and post-marketing clinical trials — based on product safety profiles, risk management plans, and regulatory requirements.

• Lead the preparation of key regulatory documents, including study outlines, implementation plans, survey forms, analysis plans, clinical study reports (CSRs), periodic safety reports, and re-examination application materials.

• Collaborate closely with internal stakeholders across development, medical, safety, and regulatory affairs — as well as global teams — to ensure aligned, compliant, and effective PMS execution.

• Engage directly with regulatory authorities: negotiate study designs, respond to inquiries, and manage consultations to reach timely agreements on PMS commitments.

• Oversee the full lifecycle of PMS studies through robust project management — from planning and implementation through data analysis, results evaluation, and regulatory reporting.

• Support re-examination application conformity investigations and address emerging regulatory or operational challenges related to post-marketing activities.

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About you

• Experience: Background in clinical research or post-marketing surveillance, including experience in study planning, data management, and statistical analysis; experience working within GxP-regulated environments is highly valued.

• Technical skills: Working knowledge of Japan's Pharmaceutical and Medical Device Act (Yakuji-ho) and GPSP regulations, or equivalent regulatory frameworks; ability to prepare high-quality regulatory and medical documents in both Japanese and English.

• Soft skills: Strategic and scientific thinker who balances regulatory compliance with innovative problem-solving; strong project management capabilities with the ability to prioritize and deliver across multiple workstreams; collaborative communicator who can build effective relationships with diverse stakeholders.

• Education: Degree in pharmacy, life sciences, medicine, or a related field (or equivalent professional experience).

• Languages: Fluency in Japanese; business-level English proficiency (reading, writing, and communication).

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Why choose us?

• Make your work count by supporting a company that brings life-changing treatments to millions — and is committed to doing right by patients, communities, and the planet.

• Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably.

• Advance your career through stretch roles, cross-functional moves, and development opportunities designed to match your ambition.

• Thrive in inclusive, high-performing teams where every role matters and every voice helps shape what's next.

• Play a strategically important role at the heart of patient safety — where your expertise directly influences how medicines are monitored and managed in the real world.

• Collaborate with global regulatory and scientific experts, gaining exposure to international best practices in risk management and pharmacovigilance.

• Be part of a team that challenges convention — bringing fresh thinking to regulatory science and shaping the future of post-marketing excellence in Japan.

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PursueProgress. DiscoverExtraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.