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Sanofi Group Global Safety Officer, Immunology and Inflammation in Bridgewater, New Jersey

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

An exciting opportunity to join a dynamic therapeutic area in Sanofi!

Internal & External Safety Expert

  • Provide PV and risk management expertise to internal and external customers

  • Safety expert for product

  • Maintain knowledge of product, product environment, and recent literature

  • Maintain PV expertise, and understanding of international safety regulations and guidelines

  • Lead cross functional Safety Management Teams (SMTs)

  • Communicate with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations

  • Provide strategic and proactive safety input into development plans

  • Support due diligence activities and pharmacovigilance agreements

Signal Detection & Assessment

  • Responsible for signal detection and analysis

  • Collaborate with Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology group

  • Identify and implement proactive safety analysis strategies to further define the safety profile

  • Lead aggregate safety data review activities and coordinate safety surveillance activities

Risk Assessment & Risk Management & Benefit-Risk Assessment

  • Provide proactive risk assessment

  • Co-lead benefit-risk assessment with other relevant functions

  • Develop risk management strategies and plans and monitor effectiveness

  • Collaborate with Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups

Submission Activities

  • Represent safety position in cross functional submission teams

  • Ensure generation, consistency, and quality of safety sections in submission documents

  • Write responses or contributions to health authorities’ questions

  • Support preparation and conduct of Advisory Committee meetings

Report Writing

  • Document, contribute to, coordinate, review and/or validate Periodic Reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report

  • Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products

About you

Knowledge & Skills

  • Excellent clinical judgment

  • Capability to synthesize and critically analyze data from multiple sources

  • Ability to communicate complex clinical issues and analysis orally and in writing

  • Able to develop and document sound risk assessment

  • Demonstrates initiative and capacity to work under pressure

  • Demonstrates leadership within cross-functional team environment

  • Excellent teamwork and interpersonal skills are required

  • Fluent in English (written and spoken)

Formal Education & Experience Required

  • M.D. Degree

  • For MD, Board Certified/Board eligible, or equivalent, is preferred

  • For M.D., minimum 3 years' and for other degrees, minimum 5 years' experience in PV

Why Choose Us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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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