Periodic Reporting Expert

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

Job title: Periodic Reporting Expert Location: Morristown, NJ

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.

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.

About you

• Education: 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.

Equal Opportunity Statement

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. #GD-SA #LI-SA #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Equal Opportunity Statement – Repeated

Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here US and Puerto Rico Residents Only Sanofi Inc. 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.

The salary range for this position is: $122,250.00 - $176,583.33 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.

Wir sind ein forschendes Biopharma-Unternehmen, das KI anwendet und sich dafür einsetzt, das Leben der Menschen zu verbessern und verantwortungsvoll zu wachsen. Unser Team wird von einem Ziel geleitet: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Wir möchten eine gesündere, widerstandsfähigere Welt schaffen und das Unmögliche möglich machen, indem wir Medikamente und Impfstoffe für Millionen von Menschen weltweit entdecken, entwickeln und bereitstellen. Erfahren Sie mehr über uns auf www.sanofi.com oder schauen Sie sich unseren Film an: We are Sanofi Starte eine Karriere, die einen Unterschied macht. Neuerfindung liegt in unserer DNA. Sie hat unsere Entwicklung von einem kleinen französischen Unternehmen zu einem der weltweit führenden Biopharma-Unternehmen vorangetrieben. Ob es darum geht, KI zu nutzen, um die Zeiten der Arzneimittelforschung zu verkürzen, oder Vertrauen im Gesundheitswesen aufzubauen – du kannst unseren Teams dabei helfen, das Leben für Patient*innen, Partner*innen und Gemeinschaften zu verbessern. Hier entwickelst du deine Karriere weiter. Wir öffnen dir die Tür, um neue Möglichkeiten zu entdecken, deine Grenzen zu erweitern und dich mit Menschen zu vernetzen, die von einem gemeinsamen Ziel angetrieben werden: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern.