Job title: Global Periodic Reporting leadLocation: Cambridge, MA / Morristown, NJ / Swiftwater, PAAbout 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. As Global Periodic Reporting Lead within our Pharmacovigilance team, you will ensure and develop robust , compliant, and controlled processes for Periodic Safety Report (PSR) authoring and vendor oversight. You will lead the Periodic Report Expert (PRE) Team through coaching and mentorship while managing the annual worldwide regulatory planning of PSRs for the entire company portfolio. You will develop and execute outsourcing strategies, uphold regulatory compliance, and drive process improvements to leverage efficiencies. Ready to get started?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. Main Responsibilities:Ensure and develop robust , compliant, and controlled processes for Periodic Safety Report (PSR) authoring and vendor oversight while upholding regulatory compliance expectationLead the Periodic Report Expert (PRE) Team through coaching, mentorship, and development planning according to individual and organizational prioritiesDevelop and execute outsourcing strategies for PSR authoring according to business criticality and resourcing needsEstablish and maintain the annual worldwide regulatory planning of PSRs for the entire company portfolio (clinical and postmarketing)Manage PSR Planning Team with regard to PSR planning activities, resource allocation, and training needsServe as system owner for the PSUR Web page Repository and tracking tool databaseIdentify, implement, and support process improvements to leverage efficiencies and drive continuous improvementAbout YouExperience:Experience in international pharmacovigilance for marketed drugs and/or projects under clinical developmentProven track record in transversal collaborationExperience compiling and drafting PSRs and safety reportsTechnical and Soft Skills:Excellent technical, clinical and critical analytical skills with keen understanding of clinical safety processes and analysisStrong understanding of global regulatory framework governing PSRs and worldwide pre and post marketing safety reporting regulations and ICH guidelinesLeadership skills including team motivation, problem-solving, initiative-taking, and strong negotiation skillsProcess improvement experience (LEAN, Continuous Improvement) and project management of multifactorial activities with successful prioritizationExcellent written and oral communication skills and computer literacyEducation:Bachelor's degree in health science or related fieldLanguages:Fluent 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 Equal Opportunity employers committed to a culturally inclusive 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 #LI-Hybrid#vhdPursue progress, discover extraordinaryBetter is out there.
Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 ( ) or click hereUS and Puerto Rico Residents OnlySanofi Inc. and its U.S.
affiliates are Equal Opportunity employers committed to a culturally inclusive 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.North America Applicants OnlyThe salary range for this position is:$178,500.00 - $257,833.33All 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.SummaryLocation: Cambridge, MA; Morristown, NJ; Swiftwater, PAType: Full time
Global Periodic Reporting Lead in somerville at Unknown Company
This position is listed as full time and hybrid.