Periodic Reporting Expert
Sanofi - Morristown, NJ
Hiring: Periodic Reporting Expert Company: Sanofi Location: Morristown, NJ Job Posted Time: 2026-09-10 11:48:25 Target Skills & Keywords : AI, Microsoft Office, Project Management, R, Regulatory Compliance, Workday About the job 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 Required Skills: •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. •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. Qualifications: •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 Compensation: •$122,250 - $176,583 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!