Job title: Global Safety OfficerLocation: Cambridge, MA / Morristown, NJAbout the jobJoin 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 SanofiWe’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.Main Responsibilities:In this role you will be active in five main areasInternal & External Safety ExpertProvide PV and risk management expertise to internal and external customersSafety expert for productMaintain knowledge of product, product environment, and recent literatureMaintain PV expertise, and understanding of international safety regulations and guidelinesLead 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 negotiationsProvide strategic and proactive safety input into development plansSupport due diligence activities and pharmacovigilance agreementsSignal Detection & AssessmentResponsible for signal detection and analysisCollaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology groupIdentify and implement proactive safety analysis strategies to further define the safety profileLead aggregate safety data review activities and coordinate safety surveillance activitiesRisk Assessment/Risk Management/Benefit-Risk AssessmentProvide proactive risk assessmentCo-lead benefit-risk assessment with other relevant functionsDevelop risk management strategies and plans and monitor effectivenessCollaborate with Center of Excellence for Risk Management and Safety EpidemiologySubmission ActivitiesRepresent safety position in cross functional submission teamsEnsure generation, consistency, and quality of safety sections in submission documentsWrite responses or contributions to health authorities’ questionsSupport preparation and conduct of Advisory Committee meetingsReport WritingDocument, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update ReportServe as the medical safety expert to the GPE Periodic Reports group for assigned projects and products About YouQualifications/Education & Work Experience:M.D. Degree or equivalentFor MD, Board Certified/Board eligible, or equivalent, is preferredMinimum 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 experienceCompetencies:Excellent clinical judgmentCapability to synthesize and critically analyse data from multiple sourcesAbility to communicate complex clinical issues and analysis orally and in writingAble to develop and document sound risk assessmentDemonstrates initiative and capacity to work under pressureDemonstrates leadership within cross-functional team environmentExcellent teamwork and interpersonal skills are requiredFluent in English (written and spoken)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 US Services and its U.S. affiliates are
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