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Sanofi Group Head of PV Excellence in Tokyo, Japan

Manage all aspects of PV Excellence Team to meet required GXP compliance as well as to contribute optimization of sanofi business. Specifically:

  • Prepare, track and ensure timely submission of local periodic reports (J-PSR, ReSD, Non-serious unlisted ADR periodic report, non-serious unlisted PTC periodic report, J-DSUR, Infection periodic report).

  • Prepare, track, and timely submission of GXP reports (Research report/Safety Measure Report).

  • Collaborate with CSU and RA departments to plan for PSRs

  • Coordination of local divestment projects and partnership

  • People management

  • Vendor management (multiple vendors)

REQUIREMENTS

  • Advanced knowledge of local pharmacovigilance legislation

  • Understanding of global requirements for pharmacovigilance by major health authorities.

  • Ability to analyze, connect and interpret complex information from multiple sources and drive thoughtful risk-taking and decision-making

  • Problem solving skills, excellent communication to a diverse audience

  • Excellent project management skills

  • Knowledge of Aggregate report tool with understanding of both business and technical requirements

  • Inclusive leader with soft skills

  • Knowledge of budget forecasting and management

  • Native level oral and written Japanese. Advanced fluency in English

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)

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