Global Periodic Reporting Lead

Global Periodic Reporting Lead

Location:

Cambridge, MA / Morristown, NJ / Swiftwater, PA

Job Description:

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.

• Ensure and develop robust, compliant, and controlled processes for PSR authoring and vendor oversight while upholding regulatory compliance expectations.
• 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.

• 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.

Bachelor’s degree in health science or related field.

Fluent English (written and spoken).

• Thoughtful, well‑crafted rewards package that recognizes the contribution and amplifies impact.
• High‑quality healthcare, prevention and wellness programs.
• At least 14 weeks’ gender‑neutral parental leave.

US and Puerto Rico Residents Only.

The salary range for this position is: $ - $. All compensation will be determined commensurate with demonstrated experience.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or liability for military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.