Global Periodic Reporting Lead

Pursue Progress, Discover Extraordinary

Better 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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Join 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.

Global Periodic Reporting Lead

Location: Cambridge, MA / Morristown, NJ / Swiftwater, PA

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 expectation
• Lead the Periodic Report Expert (PRE) Team through coaching, mentorship, and development planning according to individual and organizational priorities
• Develop and execute outsourcing strategies for PSR authoring according to business criticality and resourcing needs
• Establish 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 needs
• Serve as system owner for the PSUR Web page Repository and tracking tool database
• Identify, implement, and support process improvements to leverage efficiencies and drive continuous improvement

About You

Experience:

• Experience in international pharmacovigilance for marketed drugs and/or projects under clinical development
• Proven track record in transversal collaboration
• Experience compiling and drafting PSRs and safety reports

Technical and Soft Skills:

• Excellent technical, clinical and critical analytical skills with keen understanding of clinical safety processes and analysis
• Strong understanding of global regulatory framework governing PSRs and worldwide pre and post marketing safety reporting regulations and ICH guidelines
• Leadership skills including team motivation, problem-solving, initiative-taking, and strong negotiation skills
• Process improvement experience (LEAN, Continuous Improvement) and project management of multifactorial activities with successful prioritization
• Excellent written and oral communication skills and computer literacy

Education:

• Bachelor's degree in health science or related field

Languages:

• 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.