Global Safety Officer

Job title: Global Safety Officer

Location: Cambridge, MA; Morristown, NJ

About The Job

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

Context

As a Global Safety Officer in the field of Rare Diseases, you provide medical input on the safety evaluation of established drugs and drugs under development. This will contribute to innovative new therapies which will directly improve the life of patients.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main Responsibilities

In this role you will be active in five main areas

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) 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, 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 and 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 Safety Epidemiology
  
  
  

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, coordinate, review and 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 GPE Periodic Reports group for assigned projects and products
  
  
  

About You

Qualifications/Education & Work Experience:

• 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 (e.g. clinical development) with relevant clinical experience considered.Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience
  
  
  

Competencies

• Excellent clinical judgment
• Capability to synthesize and critically analyse 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)
  
  
  

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
  
  
  

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.