Job Information
Sanofi- Genzyme Global Safety Officer - Oncology in Cambridge, Massachusetts
Major Duties & 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 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 from health authorities, ethics committees, IRBs, external partners Management of product safety alerts Ensuring the GPE position is well articulated to and understood by its internal and external customers Signal detection and analysis Development of safety action plans and implementation, as appropriate Enable effective development of product safety Regulatory compliance Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed 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 Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products Formal Education And Experience Required 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.