Global Periodic Reporting Lead

Sanofi

Global Periodic Reporting Lead ensuring and developing robust PSR authoring processes in Pharmacovigilance. Leading the PRE Team and managing worldwide regulatory planning for a biopharma company.

Posted 7/10/2026full-timeCambridge • Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $178,500 - $257,833 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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
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
Bachelor's degree in health science or related field
Fluent English (written and spoken)

Benefits

Comp & perks

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

PSR Compilation and DraftingClinical Safety AnalysisProject ManagementResource AllocationRegulatory Compliance

Soft Skills

Team MotivationProblem-SolvingNegotiation SkillsCommunication Skills