Periodic Reporting Expert

About the role

The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-edge safety group, enabling optimization of the benefit-risk of our therapies to best serve our patients and consumers.

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

• 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.
• 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 Pharmacovigulation 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.

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.

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.
• Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.