Global Safety Officer, I&I

Main Responsibilities

• 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) 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
• Ongoing assessment of the safety status of the product
• Impact: Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
• Impact: Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners
• Impact: Management of product safety alerts
• Impact: Ensuring the GPE position is well articulated to and understood by its internal and external customers
• Impact: Establishment of credibility of GSO function and of GPE
• Signal Detection And Assessment: Responsible for signal detection and analysis
• Impact: Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
• Impact: Identify and implement proactive safety analysis strategies to further define the safety profile
• Impact: Lead aggregate safety data review activities and coordinate safety surveillance activities
• Risk Assessment/Risk Management/ Benefit-Risk Assessment: Provide proactive risk assessment
• Impact: Co-lead benefit-risk assessment with other relevant functions
• Impact: Develop risk management strategies and plans and monitor effectiveness
• Impact: Collaborate with Center of Excellence for Risk Management and Safety Epidemiology
• Submission Activities: Represent safety position in cross functional submission teams
• Impact: Ensure generation, consistency, and quality of safety sections in submission documents
• Impact: Write responses or contributions to health authorities’ questions
• Impact: Support preparation and conduct of Advisory Committee meetings
• Report Writing: Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
• Impact: Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.

  About You

  • Excellent clinical judgment
  • Capability to synthesize and critically analyze data from multiple sources
  • 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)

  About Sanofi

  • We are an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
  • Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world.
  • Together, we chase the miracles of science to improve people’s lives.

  Knowledge and Skills

  • Excellent clinical judgment
  • Capability to synthesize and critically analyze data from multiple sources
  • 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)

  About You

  • 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.

  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.

  Salary Range

  The Salary Range For This Position Is $178,500.00 - $297,500.00

  Additional Information

  • All compensation will be determined commensurate with demonstrated experience.
  • Employees may be eligible to participate in Company employee benefit programs.
  • Additional benefits information can be found here.