Periodic Reporting Expert

Main Responsibilities

• Expert on the global regulatory framework impacting global periodic reporting including the pharmacovigilance practices that impact the safety messaging of our products.
• Lead the proactive, cross-functional coordination of global periodic safety reports to ensure regulatory submission compliance.
• Participate and author health authority responses pertaining to global periodic reporting processes and content.
• Champion continuous improvement actions that drive automation, efficiency, and quality improvement.
• Provide mentorship and training on regulatory and process expectations to vendors, Sanofi collaborators, and global partners.

About You

• About You: Bachelor's degree (BS) in Biology, Chemistry, Biochemistry, Physics, or related scientific field with relevant experience, OR PharmD (Preferred), OR Other Healthcare Professional (HCP) degree with relevant experience.
• Experience: BS with a minimum of 4 years of industry experience and 2 years minimum of Pharmacovigilance experience OR PharmD with a minimum of 3 years of clinical or industry experience and 2 years minimum of Pharmacovigilance experience.

Education

Education: Bachelor's degree (BS) in Biology, Chemistry, Biochemistry, Physics, or related scientific field with relevant experience, OR PharmD (Preferred), OR Other Healthcare Professional (HCP) degree with relevant experience.

Technical Skills

• Fluency in ICH and GVP guidelines.
• Proficiency in Microsoft and Sanofi applications (Viva, Workday, and/or standard Sanofi systems).

Soft Skills

• Proactive project management experience including multi-tasking of deliverables with competing timelines.
• Flexibility to adapt to changing priorities and delays.
• Comfortable leading cross-functional meetings in English.
• Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment.