Periodic Reporting Expert

**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._ 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. 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](https://cscontactus.sanofi.us/accessibilityQuestionComments.aspx) _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. _North America Applicants Only_ 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.](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fbenefits.sanofiusallwell.com%2Ffleet%2Fpublic%2Findex%2Fba511bf8-5c32-4828-9861-ab985fffab90%2F%3Fcid%3Dsanofi&data=05%7C02%7CMuhammad.Khanzada2%40sanofi.com%7C58d63db42fae425c386708def782ce2c%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C639220338481842237%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=LopUyoJYYVCvnMzJTEf9BHYbvQ8GN4nYq%2FfpZh%2BR8DM%3D&reserved=0)