Job title: Pharmacovigilance Quality & Compliance Manager Location: Tokyo ---------------- 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 Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.

Pharmacovigilance Quality & Compliance Manager.

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