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Global Safety Officer

AT Sanofi U.S.
Sanofi U.S.

Global Safety Officer

•Gunnison, CO

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?

As a Global Safety Officer in the field of Rare Diseases, you provide medical input on the safety evaluation of established drugs and drugs under development. This will contribute to innovative new therapies which will directly improve the life of patients.

In this role you will be active in five main areas

Internal & External Safety Expert

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

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  • 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) and GPE internal Safety Analysis Teams (SATs)
  • Communicate with and represent PV position within project/product teams, 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
  • Responsible for signal detection and analysis
  • Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
  • 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 Safety Epidemiology
  • 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

    Qualifications/Education & Work Experience
    • M.D. Degree or equivalent
    • For MD, Board Certified/Board eligible, or equivalent, is preferred
    • For M.D., minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered.Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience

    Competencies
    • Excellent clinical judgment
    • Capability to synthesize and critically analyse data from multiple sources
    • Ability to communicate complex clinical issues and analysis orally and in writing
    • Able to develop and document sound risk assessment

    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): United States
    Job ID: Sanofi-https://jobs.sanofi.com/en/job/cambridge/global-safety-officer/2649/17135835712
    Employment Type: Other

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