Global Periodic Safety Reporting Lead

Sanofi; Morristown (NJ); On-site; USD 122,000 - 177,000; Full time

Job summary

Sanofi in Morristown, NJ seeks a Periodic Reporting Expert to lead global PSURs, PBRERs, and DSURs, ensuring regulatory compliance and high scientific rigor.

You will collaborate across internal teams and with vendors, mentor colleagues, and drive improvements in automation, quality, and efficiency throughout the periodic reporting lifecycle. This role offers exposure to international pharmacovigilance and the chance to contribute to patient safety worldwide.

Qualifications

• Bachelor's degree in biology, chemistry, biochemistry, physics or related field; PharmD preferred.
• 2+ years in pharmacovigilance or regulatory reporting for PharmD/HCP.
• Strong knowledge of ICH/GVP and applicability to periodic reporting.
• Proficiency with Microsoft Office and Sanofi applications (Viva, Workday).
• Proven project management, English communication, and cross-functional collaboration.

Responsibilities

• Lead global regulatory frameworks and pharmacovigilance practices for periodic reporting.
• Coordinate PSURs, PBRERs, DSURs across global teams and partners.
• Author responses to health authorities regarding periodic reporting.
• Drive automation, efficiency, and quality throughout the reporting lifecycle.
• Mentor vendors and Sanofi collaborators on regulatory expectations.

Skills

Regulatory knowledge

Project management

Cross-functional collaboration

English communication

Viva/Workday familiarity

Microsoft Office

Education

BS in Biology/Chemistry/Pharmacology

PharmD preferred

Other Healthcare Professional degree

Tools

Viva

Workday

Sanofi systems

Regulatory databases

Job description

Sanofi in Morristown, NJ seeks a Periodic Reporting Expert to lead global PSURs, PBRERs, and DSURs, ensuring regulatory compliance and high scientific rigor.

You will collaborate across internal teams and with vendors, mentor colleagues, and drive improvements in automation, quality, and efficiency throughout the periodic reporting lifecycle. This role offers exposure to international pharmacovigilance and the chance to contribute to patient safety worldwide.