Global Safety Officer

Sanofi • Morristown, MA

11d • Onsite

About The Position

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi: We’re 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.

Requirements

• Excellent clinical judgment
• Articulate and clearly understood in telephone communications
• Capability to synthesize and critically analyze data from multiple sources supported by sound clinical reasoning
• 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 and with a good sense of Prioritization of business critical deliverables
• Demonstrates leadership within cross-functional team environment
• Excellent teamwork and interpersonal skills are required
• Fluency in English (written and spoken).
• M.D., D.O. or equivalent
• Minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered.

Nice To Haves

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

Responsibilities

• Internal & External Safety Expert with a clear and contemporary understand of Benefit Risk: Provide PV and risk management expertise to internal and external customers
• Safety expert for product must have an attitude of continuous learning and understand the product attributes and science
• Maintain knowledge of product, product environment, and recent literature
• Maintain expertise in drug safety and PV, and understanding of international safety regulations and guidelines
• Lead cross functional Safety Management Teams (SMTs) and GPV 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
• 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
• Review, preparation, and/or contribution to questions/requests from health authorities, ethics committees/ IRBs, external partners
• Management of product safety alerts
• Ensuring the GPV’s position is well articulated to and understood by its internal and external stakeholders
• Continued visibility and Establishment of the credibility of GSO role/function and consequently GPV
• Signal Detection and Assessment: Responsible for overseeing from multiple contributors signal detection and analysis
• Collaborate with Center of Excellence for Signal Detection and Data Mining and the Safety Epidemiology group
• Identify and implement proactive safety analysis strategies to further define the safety as well as Benefit Risk profile.
• Lead the review of aggregate safety data and related activities as well as coordinate safety surveillance activities

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees