Global Periodic Reporting Lead

BioSpace; Cambridge (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Sanofi is seeking a Global Periodic Reporting lead to head the PSR program across multiple sites in the US. You will guide the Periodic Report Expert team, shape outsourcing strategies, and drive worldwide planning for PSRs spanning clinical and postmarketing portfolios.

You will bring extensive pharmacovigilance experience, strong regulatory knowledge, and leadership to ensure compliant, efficient reporting processes and continuous improvement across the safety organization.

Qualifications

• Experience in international pharmacovigilance for marketed drugs.
• Proven cross-functional collaboration.
• Experience compiling PSRs and safety reports.

Responsibilities

• Ensure compliant processes for PSR authoring and vendor oversight.
• Lead the PRE Team through coaching and development planning.
• Develop outsourcing strategies for PSR authoring.
• Coordinate annual worldwide regulatory PSR planning.
• Manage PSR Planning Team's activities and training needs.
• Serve as system owner for the PSUR repository and tracking tools.

Skills

Leadership

Project management

Regulatory compliance

Team coaching

Analytical skills

Education

Bachelor's degree in health science or related field

Tools

PSUR Web page Repository

Job description

Job title: Global Periodic Reporting lead

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

About The Job

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples 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 its 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.

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.