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Global Safety Officer, Immunology and Inflammation

AT Sanofi U.S.
Sanofi U.S.

Global Safety Officer, Immunology and Inflammation

Bridgewater, NJ

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!

  • 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

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  • 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

    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' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development)

    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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    Client-provided location(s): Bridgewater, NJ, USA; Cambridge, MA, USA
    Job ID: Sanofi-https://jobs.sanofi.com/en/job/cambridge/global-safety-officer-immunology-and-inflammation/2649/19176885248
    Employment Type: Other