Global Periodic Reporting Lead

Sanofi•Cambridge, MA

2d•$178,500 - $257,833•Hybrid

About The Position

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.

Requirements

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
Fluent English (written and spoken)

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