Periodic Reporting Expert

Sanofi; Swiftwater (Monroe County); On-site; USD 90,000 - 120,000; Full time

Job summary

Sanofi invites a Periodic Reporting Expert to lead global periodic safety reporting within the PSPV team in Morristown, NJ. You will drive PSURs, PBRERs, and DSURs, coordinating with internal and external partners to ensure high-quality, compliant submissions.

You will mentor vendors and colleagues, push process improvements, and operate in an international, AI-enabled regulatory environment. A strong background in pharmacovigilance and regulatory science is essential.

Qualifications

• BS in Biology, Chemistry, Biochemistry, Physics, or related field (or equivalent).
• PharmD preferred or other HCP degree with relevant experience.
• Minimum 2–3 years in Pharmacovigilance or related regulatory field.

Responsibilities

• Serve as SME on global regulatory frameworks and pharmacovigilance for periodic reporting.
• Lead cross-functional coordination of PSURs, PBRERs, DSURs for timely submissions.
• Author/respond to health authority communications on periodic reporting.

Skills

ICH/GVP knowledge

Viva/Workday systems

Project management

English cross-functional meetings

Education

BS in biology/chemistry/biochem/physics or related

PharmD (preferred)

HCP degree with relevant experience

Tools

Microsoft Office

Viva

Workday

Job description

About The Job

At Sanofi, Patient Safety & Pharmacovigilance (PSPV) is at the forefront of protecting patients and optimizing the benefit-risk profile of our therapies. We leverage cutting-edge science, artificial intelligence, and global collaboration to ensure that every product we bring to market is safe, effective, and continuously monitored.

We are looking for a Periodic Reports Expert to join our Global Periodic Reports Team and play a critical role in ensuring regulatory compliance, driving scientific rigor, and communicating Sanofi's unwavering commitment to patient safety across the globe.

In this role, you will lead cross-functional collaboration with internal teams and external partners to deliver high-quality periodic safety reports that meet global regulatory standards. You'll have the opportunity to shape safety narratives, mentor colleagues and vendors, champion process improvements, and expand your expertise in a dynamic, international environment.

If you're passionate about patient safety, thrive in a fast-paced regulatory landscape, and want to make a tangible impact on the lives of millions, we'd love to hear from you. 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.

Job title

Periodic Reporting Expert

• Location: Morristown, NJ

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people's lives.

Main Responsibilities

• Serve as a subject matter expert on global regulatory frameworks and pharmacovigilance practices impacting periodic safety reporting.
• Lead the proactive, cross-functional coordination of global periodic safety reports (PSURs, PBRERs, DSURs) to ensure timely and compliant regulatory submissions.
• Author and participate in health authority responses related to periodic reporting processes and content.
• Champion continuous improvement initiatives that drive automation, efficiency, and quality across the periodic reporting lifecycle.
• Provide mentorship and training on regulatory expectations and best practices to vendors, Sanofi collaborators, and global partners.

Education

About you

• Bachelor's degree (BS) in Biology, Chemistry, Biochemistry, Physics, or a related scientific field, OR
• PharmD (Preferred), OR
• Other Healthcare Professional (HCP) degree with relevant experience

Experience

• BS holders: Minimum of 3 years of industry experience, including at least 1 year in Pharmacovigilance, OR
• PharmD holders and HCP: Minimum of 2 years of clinical or industry experience, including at least 1 year in Pharmacovigilance

Technical Skills

• Strong knowledge of ICH and GVP guidelines and their application to periodic safety reporting.
• Proficiency in Microsoft Office and Sanofi applications (Viva, Workday, and standard Sanofi systems).

Soft Skills & Competencies

• Proven project management skills with the ability to manage multiple deliverables and competing timelines.
• Flexibility and adaptability to navigate changing priorities and unexpected delays.
• Comfortable leading cross-functional meetings in English with diverse, international teams.
• Strong interpersonal and collaboration skills, with the ability to work productively in a multicultural, global environment.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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; affectional or 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.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.