Global Periodic Safety 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

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.