Global Safety Officer, Oncology

Job Title: Global Safety Officer, Oncology

Location: Cambridge, MA, Morristown, NJ

About the Job

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?

Main Responsibilities:

Management responsibilities

• Ensure alignment with the Therapeutic Area (TA) objectives, safety strategy and issue escalation with the Therapeutic Area Head (TAH) and Pharmacovigilance (PV) Head

• Oversee third-party safety providers during acquisition and development periods to ensure Sanofi safety governance processes are integrated

Internal and 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 positions 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, Health Authorities, and during internal and external negotiations

• Provide strategic and proactive safety input into development plans

• Support due diligence activities and PV agreements 

Signal Detection and Assessment:

• Responsible for signal detection and analysis

• Collaborate with Center of Excellence and Epidemiology for signal detection, safety and data mining

• 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 and Skills

·       Excellent clinical judgment