Global Safety Officer, I&I

Sanofi • Cambridge, MA

125d • $172,500 - $287,500

About The Position

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 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?

Requirements

• M.D. Degree or equivalent
• For MD, Board Certified/Board eligible, or equivalent, is preferred
• Minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience
• Proven excellence in a similar prior position may be considered even if less than 3 years international PV experience

Nice To Haves

• 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
• 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)

Responsibilities

• Provide PV and risk management expertise to internal and external customers
• Maintain knowledge of product, product environment, and recent literature
• Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
• Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities
• Support due diligence activities and pharmacovigilance agreements
• 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
• Management of product safety alerts
• Establishment of credibility of GSO function and of GPE
• Responsible for signal detection and analysis
• Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
• Provide proactive risk assessment
• Co-lead benefit-risk assessment with other relevant functions
• Develop risk management strategies and plans and monitor effectiveness
• Represent safety position in cross functional submission teams
• Document, coordinate, review and validate Periodic reports

Benefits

• High-quality healthcare
• Prevention and wellness programs
• At least 14 weeks’ gender-neutral parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees