Periodic Reporting Expert

Morristown, NJ

Cambridge, MA

Swiftwater, PA

Full time

R2869526

** 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…