Global Periodic Reporting Lead

Sanofi; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Sanofi in the US seeks a Global Periodic Reporting Lead based in Cambridge, MA (also Morristown, NJ and Swiftwater, PA). You will own the PSR authoring process, oversee vendor oversight, and mentor the PRE Team while coordinating annual worldwide PSR planning across the portfolio.

You will develop outsourcing strategies, ensure regulatory compliance, and drive Lean process improvements to boost efficiency and data integrity in safety reporting, with a focus on ICH guidelines and global

Qualifications

• 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.

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

Skills

Analytical skills

Regulatory knowledge

Leadership

LEAN / CI

Communication skills

Education

Bachelor's degree in health science or related field

Job description

Job title: Global Periodic Reporting lead

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

About The Job

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.

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 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.

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.

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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.