R&D
Where your curiosity drives the
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Pharmacovigilance Quality & Compliance Manager
At a glance
Bring your curiosity to a team where deep immunoscience meets cutting-edge innovation. Across oncology, rare diseases, neurology, and vaccines, you’ll work at the intersection of lab science and AI-powered discovery — all while collaborating across boundaries to turn breakthrough ideas into real-world impact. Whether you want to deepen your scientific expertise or grow as a leader, you’ll find the opportunity here.
Job title: Pharmacovigilance Quality & Compliance Manager
- Location: Tokyo
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Job role - Fulfill responsibility that processes to comply with local PV regulations and the global procedures are implemented, documented and followed locally (QD management, self-inspection, etc.)
- Fulfill responsibility on creation and revision of SDEA, PV contract for safety information exchange and/or GVP and non-GVP agreement. Serves as a consultant/advisor GPV contracts serving Japan PV business.
- Fulfil responsibility on storage including document transfer at a transfer of approval. Window person of document management in Japan PV.
- Take control Audit and Inspection and its preparation. Coordination of GVP inspection and GxP Audit. Hard knowledge and experience about Audit/Inspection.
- Fulfill responsibility to lead Quality in J-PSPV by conducting “self-inspection”, “Change Management, and “Deviation Management /CAPA implementation” .Understand the Global Quality process and implement it to Japan considering local regulation.
- Within Japan organization, to be a window person of training about general topic and local regulation for safety mutters. Keep communication to global training leader and implement to Japan. Leader of Japan GVP training program.
Personal requirements
- Ability to create and implement appropriate safety processes from quality and compliance standpoint.
- High level of coordination, communication and negotiation skills.
- Solid knowledge of audit/inspection, experience with Japan GVP.
- Commitment and ethical standard to fulfill responsibility in keeping SaKK in compliance with both global and local PV regulatory obligations
Pursue Progress. Discover Extraordinary.
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.
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Why work with us
- Expand your horizons. Grow through curiosity, with support to move, learn, and lead in a culture that champions mentorship, mobility, and bold development.
- Accelerate results with technology. Harness the power of AI and automation to push scientific boundaries and reimagine what's possible in drug discovery.
- Impact through inclusive innovation. Help deliver better science and fairer outcomes by driving inclusive research that reaches more people, in more meaningful ways.
- Turn patient needs into breakthrough science. Drive scientific breakthroughs that start with patient needs – and end in treatments that change lives.
Meet Nils Libert, Associate Scientist
Meet Nils Libert, an Associate Scientist in Belgium, where he plays a key role in advancing groundbreaking research. Learn how his work helps drive innovation, uncover new scientific possibilities, and contribute to life-changing treatments that impact patients around the world.
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Discover how we're reshaping the future of medicine through immunoscience – unlocking bold, cross-disease breakthroughs that were unimaginable just a decade ago.
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