Global PSR Lead — Pharmacovigilance Excellence

Sanofi; Morristown (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Sanofi seeks a Global Periodic Reporting Lead in our Pharmacovigilance team to drive robust PSR authoring and vendor oversight across the company portfolio. You will lead the PRE Team, coach staff, and manage the worldwide annual PSR planning with a focus on compliance and outsourcing strategies.

Based in Cambridge, MA / Morristown, NJ / Swiftwater, PA, this role requires international pharmacovigilance experience, strong collaboration, and a Bachelor’s in health science or related field.

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 compliant PSR authoring and vendor oversight while upholding regulatory expectations.
• Lead the PRE Team through coaching, mentorship, and development planning.
• Develop and execute outsourcing strategies for PSR authoring.
• Establish and maintain the annual worldwide regulatory planning of PSRs.
• Manage PSR Planning Team regarding planning activities, resources, training.
• Serve as system owner for the PSUR Web page Repository and tracking tool.
• Identify and implement process improvements to drive efficiency.

Skills

Leadership

Project management

Regulatory knowledge

Analytical skills

Communication

Education

Bachelor's degree in health science or related field

Job description

Sanofi seeks a Global Periodic Reporting Lead in our Pharmacovigilance team to drive robust PSR authoring and vendor oversight across the company portfolio. You will lead the PRE Team, coach staff, and manage the worldwide annual PSR planning with a focus on compliance and outsourcing strategies.

Based in Cambridge, MA / Morristown, NJ / Swiftwater, PA, this role requires international pharmacovigilance experience, strong collaboration, and a Bachelor’s in health science or related field.