Role & Responsibilities
• Perform medical review and assessment of individual case reports of adverse events (AEs) and other safety information related to Sanofi products
• Review and evaluate medical information from case reports, determining the causality assessment
• Prepare detailed and thorough safety narratives
• Participate in the medical evaluation of safety signals, risk management planning, and benefit-risk assessment
• Respond to medical information requests from healthcare providers, patients, and regulatory authorities
• Provide medical expertise and input to cross-functional teams, including regulatory affairs and clinical teams
Qualification
• Medical degree (MBBS, MD, or equivalent)
• 3+ years of experience in pharmacovigilance, drug safety, or a related field
Experience
• Proven experience in reviewing adverse events, causality assessment, and preparing safety narratives
• Familiarity with safety signal management and risk management strategies
• Experience working with cross-functional teams in a pharmaceutical or biopharmaceutical company
Skills
• Medical review and evaluation of adverse events
• Causality assessment and benefit-risk assessment
• Strong understanding of safety information processing and reporting
• Ability to respond to medical information requests and provide expertise to healthcare providers
• Excellent communication and collaboration skills
About The Company
• Sanofi – A global biopharmaceutical company focused on human health. Sanofi is dedicated to discovering, developing, and distributing therapeutic solutions to improve the lives of people facing serious illnesses.
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