Periodic Reporting Expert

Sanofi•Cambridge, MA

7d•$122,250 - $176,583•Onsite

About The Position

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.

Requirements

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
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
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).
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.

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.