Job Description

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

An exciting opportunity to join a dynamic therapeutic area in Sanofi!

Internal & External Safety Expert

• Provide PV and risk management expertise to internal and external customers
• Safety expert for product
• 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 with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
• Provide strategic and proactive safety input into development plans
• Support due diligence activities and pharmacovigilance agreements

Signal Detection & Assessment

• Responsible for signal detection and analysis
• Collaborate with Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology group
• Identify and implement proactive safety analysis strategies to further define the safety profile
• Lead aggregate safety data review activities and coordinate safety surveillance activities

Risk Assessment & Risk Management & Benefit-Risk Assessment

• Provide proactive risk assessment
• Co-lead benefit-risk assessment with other relevant functions
• Develop risk management strategies and plans and monitor effectiveness
• Collaborate with Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups

Submission Activities

• Represent safety position in cross functional submission teams
• Ensure generation, consistency, and quality of safety sections in submission documents
• Write responses or contributions to health authorities' questions
• Support preparation and conduct of Advisory Committee meetings

Report Writing

• Document, contribute to, coordinate, review and/or validate Periodic Reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
• Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products

About you

Knowledge & Skills

• 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
• Demonstrates initiative and capacity to work under pressure
• Demonstrates leadership within cross-functional team environment
• Excellent teamwork and interpersonal skills are required
• Fluent in English (written and spoken)

Formal Education & Experience Required

• M.D. Degree
• For MD, Board Certified/Board eligible, or equivalent, is preferred
• For M.D., minimum 3 years' and for other degrees, minimum 5 years' experience in PV

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