Global PSR Strategy Lead

Sanofi; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Sanofi in the US seeks a Global Periodic Reporting Lead based in Cambridge, MA (also Morristown, NJ and Swiftwater, PA). You will own the PSR authoring process, oversee vendor oversight, and mentor the PRE Team while coordinating annual worldwide PSR planning across the portfolio.

You will develop outsourcing strategies, ensure regulatory compliance, and drive Lean process improvements to boost efficiency and data integrity in safety reporting, with a focus on ICH guidelines and global

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, 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

Skills

Analytical skills

Regulatory knowledge

Leadership

LEAN / CI

Communication skills

Education

Bachelor's degree in health science or related field

Job description

Sanofi in the US seeks a Global Periodic Reporting Lead based in Cambridge, MA (also Morristown, NJ and Swiftwater, PA). You will own the PSR authoring process, oversee vendor oversight, and mentor the PRE Team while coordinating annual worldwide PSR planning across the portfolio.

You will develop outsourcing strategies, ensure regulatory compliance, and drive Lean process improvements to boost efficiency and data integrity in safety reporting, with a focus on ICH guidelines and global