Periodic Reporting Expert
Sanofi
September 04, 2026
On-site
Morristown, NJ
$122,250 - $176,583.33 USD yearly
Operations
Main Responsibilities
- Serve as a subject matter expert on global regulatory frameworks and pharmacovigilance practices impacting periodic safety reporting.
- Lead 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.
Qualifications / Education
- Bachelor’s degree (BS) in Biology, Chemistry, Biochemistry, Physics, or related field, OR
- PharmD (Preferred), OR
- Other Healthcare Professional (HCP) degree with relevant experience.
Experience
- BS holders: Minimum 3 years industry experience, including at least 1 year in Pharmacovigilance.
- PharmD and HCP: Minimum 2 years 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; ability to manage multiple deliverables and competing timelines.
- Flexibility/adaptability to changing priorities and delays.
- Comfortable leading cross-functional meetings in English with international teams.
- Strong interpersonal and collaboration skills in a multicultural environment.
Benefits (explicitly stated)
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Serve as a subject matter expert on global regulatory frameworks and pharmacovigilance practices impacting periodic safety reporting.
- Lead 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.
Qualifications / Education
- Bachelor’s degree (BS) in Biology, Chemistry, Biochemistry, Physics, or related field, OR
- PharmD (Preferred), OR
- Other Healthcare Professional (HCP) degree with relevant experience.
Experience
- BS holders: Minimum 3 years industry experience, including at least 1 year in Pharmacovigilance.
- PharmD and HCP: Minimum 2 years 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; ability to manage multiple deliverables and competing timelines.
- Flexibility/adaptability to changing priorities and delays.
- Comfortable leading cross-functional meetings in English with international teams.
- Strong interpersonal and collaboration skills in a multicultural environment.
Benefits (explicitly stated)
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.