Periodic Reporting Expert

Location: Morristown, NJ / Cambridge, MA / Swiftwater, PA Periodic Reporting Expert The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-edge safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers. Are you ready to champion patient safety? The race is on to leverage artificial intelligence to support continuous improvement and build scientific and leadership capabilities. Your skills could be critical in helping our team in Patient Safety and Pharmacovigilance (PSPV) to ensure regulatory compliance and strong benefit-risk assessments that reinforce the value of Sanofi’s portfolio to patients and their families. Join our Global Periodic Reports Team as a Periodic Reports Expert and you will lead collaboration across Sanofi contributors and our global partners to communicate Sanofi’s commitment to patient safety. You will also enjoy the opportunity to broaden your experience and personal network while honing your leadership skills. 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. Main Responsibilities Expert on the global regulatory framework impacting global periodic reporting including the pharmacovigilance practices that impact the safety messaging of our products. Lead the proactive, cross-functional coordination of global periodic safety reports to ensure regulatory submission compliance. Participate and author health authority responses pertaining to global periodic reporting processes and content. Champion continuous improvement actions that drive automation, efficiency, and quality improvement. Provide mentorship and training on regulatory and process expectations to vendors, Sanofi collaborators, and global partners. Qualifications Bachelor’s degree (BS) in Biology, Chemistry, Biochemistry, Physics, or related scientific field with relevant experience, or PharmD (preferred), or other Healthcare Professional (HCP) degree with relevant experience. BS with a minimum of 4 years of industry experience and at least 2 years of Pharmacovigilance experience, or PharmD with a minimum of 3 years of clinical or industry experience and at least 2 years of Pharmacovigilance experience. Technical Skills Fluency in ICH and GVP guidelines. Proficiency in Microsoft and Sanofi applications (Viva, Workday, and/or standard Sanofi systems). Soft Skills Proactive project management experience including multitasking deliverables with competing timelines. Flexibility to adapt to changing priorities and delays. Comfortable leading cross-functional meetings in English. Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment. 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. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Help improve the lives of millions of people globally by making drug development quicker and more effective. Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. Equal Employment Opportunity Sanofi Inc. and its U.S. affiliates are Equal Opportunity and 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, 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. #J-18808-Ljbffr BioSpace