Global Safety Officer, I&I

About This Role

Serve as a Global Safety Officer for Sanofi's Immunology & Inflammation (I&I) therapeutic area, providing pharmacovigilance and risk management expertise for product safety. This role drives breakthroughs in R&D to improve people's lives globally.

Responsibilities

• Provide PV and risk management expertise to internal and external customers
• Act as safety expert for assigned products
• Maintain knowledge of product, product environment, and recent literature
• Maintain PV expertise and understanding of international safety regulations and guidelines
• Lead cross-functional Safety Management Teams (SMTs)
• Communicate PV analyses and positions within project/product teams, safety governance, and with external partners and Health Authorities
• Provide strategic and proactive safety input into development plans
• Support due diligence activities and pharmacovigilance agreements
• Responsible for signal detection and analysis, collaborating with COE for Signal Detection and Data Mining
• Develop risk management strategies and plans and monitor effectiveness

Requirements

• M.D. Degree
• Minimum 3 years total experience in international pharmacovigilance or relevant clinical development
• Excellent clinical judgment
• Capability to synthesize and critically analyze data from multiple sources
• Ability to communicate complex clinical issues and analysis orally and in writing
• Able to develop and document sound risk assessment
• Fluent in English (written and spoken)

Qualifications

• M.D. Degree
• Minimum 3 years total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered.

Nice to Have

• Board Certified/Board eligible

Benefits