Job title: Periodic Reporting Expert
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.
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
