SANOFI

Qualité Sécurité Environnement

La vocation de Sanofi est d’accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d’une maladie chronique. Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l’innovation scientifique en solutions de santé partout dans le monde. Sanofi, Empowering Life, donner toute sa force à la vie. Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d’inclusion et créer un environnement de travail où ces différences peuvent s’épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous.

Job Summary Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. The Pharmacovigilance, Global Safety (MD) is the safety expert and safety lead for Sanofi products. Major Duties & Responsibilities Internal & External Safety Expert Provide 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 agreements Signal Detection and Assessment Responsible 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 profile.Lead aggregate safety data review activities and coordinate safety surveillance activities Risk Assessment/Risk Management/Benefit-Risk Assessment Provide 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 Epidemiology Submission Activities Represent safety position in cross functional submission teamsEnsure generation, consistency, and quality of safety sections in submission documentsWrite responses or contributions to health authoritiesSupport 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 ReportServe as the medical safety expert to the GPE Periodic Reports group for assigned projects and products. Major Challenges & Problems Providing product safety leadership within project teams having multiple and at times competing priorities and timelinesChampioning the GPE position within a large and complex organizationDetermining the appropriate risk minimization and mitigation measures in light of -B/R assessment in coordination withdifferent partiesAddressing internal and external customer queries, including those from Health Authorities, in a rapid and effective manner and within appropriate timelines. The above challenges are effectively managed through strong leadership and communication skills paired with an assertive yet collaborative approach, a high level of medical and scientific Key Internal/External Relationships Internal: other GPE Units, R&D Units and Business Divisions, Scientific Core Platforms, Medical and Regulatory Affairs, Franchise(s), Legal Department, Communication, Affiliates (APH)External: Regulatory/Competent Authorities, Ethics Committee, Investigators, Data Monitoring Committees, partners, CROs Decision Making Authority Identify potential signals/issues of pharmacovigilance and evaluate product safetyRecommend/discuss and coordinate appropriate course of actionAsk project/product team for necessary amendments, labelling modifications/variationsLead SMT and SATApprove safety regulatory and clinical documents including submission, transversal and primary GPE documents as per SOP Information/Decisions to be referred to hierarchy Transmission of any decision with impact on Study Conduct (e.g. Clinical Hold)Transmission of any safety concerns for which GSO is informed (e.g. Health -Authority restriction/decision) Basic Qualifications M.D. Degree REQUIREDMinimum 3 years total experience in international pharmacovigilance Preferred Qualifications Board Certified/Board eligible, or equivalentExcellent clinical judgmentCapability to synthesize and critically analyze 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 environmentExperience in Immunology 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. #GD-SG #LI-GZ