Global Periodic Safety Reporting Lead

Sanofi; Swiftwater (Monroe County); On-site; USD 140,000 - 190,000; Full time

Job summary

Sanofi is seeking a Global Periodic Reporting Lead to drive PSR authoring, vendor oversight, and global PSR planning. You will mentor the PRE Team and oversee outsourcing strategies to ensure regulatory compliance across the portfolio.

Ideal candidates bring international pharmacovigilance experience, cross-functional collaboration, and strong leadership to optimize safety reporting processes and drive continuous improvement.

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 PSR authoring and vendor oversight processes.
• Lead the PRE Team through coaching and development planning.
• Develop outsourcing strategies for PSR authoring based on business needs.
• Manage worldwide annual regulatory planning of PSRs for the company portfolio.
• Oversee PSR planning activities, resource allocation, and training needs.
• Act as system owner for the PSUR Web page Repository and tracking tool.
• Identify and implement process improvements to drive efficiency.

Skills

Pharmacovigilance

PSR drafting

Cross-functional collaboration

Education

Bachelor's degree in health science or related field

Job description

Sanofi is seeking a Global Periodic Reporting Lead to drive PSR authoring, vendor oversight, and global PSR planning. You will mentor the PRE Team and oversee outsourcing strategies to ensure regulatory compliance across the portfolio.

Ideal candidates bring international pharmacovigilance experience, cross-functional collaboration, and strong leadership to optimize safety reporting processes and drive continuous improvement.