Global Safety Officer

Role Summary

Global Safety Officer based in Morristown, NJ or Cambridge, MA, responsible for pharmacovigilance leadership, safety strategy, and cross-functional safety management. Oversees signal detection, risk assessment, and regulatory communications to ensure safe development and lifecycle management of Sanofi products.

Responsibilities

• Provide PV and risk management expertise to internal and external customers
• Safety expert for product with continuous learning and understanding of product attributes and science
• Maintain knowledge of product, product environment, and recent literature
• Maintain expertise in drug safety and PV, and understanding of international safety regulations and guidelines
• Lead cross functional Safety Management Teams (SMTs) and GPV internal Safety Analysis Teams (SATs)
• Communicate with and represent PV position within project/product teams, 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
• Ongoing assessment of the safety status of the product
• Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
• Review, preparation, and/or contribution to questions/requests from health authorities, ethics committees/ IRBs, external partners
• Management of product safety alerts
• Ensuring the GPV’s position is well articulated to and understood by internal and external stakeholders
• Establishment of the credibility of GSO role/function and GPV Signal Detection and Assessment; oversee signal detection and analysis from multiple contributors
• Collaborate with Center of Excellence for Signal Detection and Data Mining and the Safety Epidemiology group
• Identify and implement proactive safety analysis strategies to define safety and Benefit Risk profile
• Lead the review of aggregate safety data and coordinate safety surveillance activities

Qualifications

• Required: M.D., D.O. or equivalent
• Preferred: Board Certified/Board eligible, or equivalent
• Required: Minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g., clinical development) with relevant clinical experience; exceptional candidates with proven excellence in a similar position may be considered with less than 3 years international PV experience

Skills

• Excellent clinical judgment
• Articulate and clear in telephone communications
• Ability to synthesize and critically analyze data from multiple sources with sound clinical reasoning
• Ability to communicate complex clinical issues in writing and orally
• Develop and document sound risk assessments
• Demonstrates initiative and ability to work under pressure with prioritization of critical deliverables
• Demonstrates leadership within cross-functional teams
• Excellent teamwork and interpersonal skills
• Fluency in English (written and spoken)

Education

• Required: M.D., D.O. or equivalent
• Preferred: Board Certified/Board eligible, or equivalent