Global Safety Officer

Job title: Global Safety Officer

Location: Cambridge, MA; Morristown, NJ

About the job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll 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 

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s 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. <