Global Safety Officer, Oncology

Job Title: Global Safety Officer, Oncology

Location: 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

Internal & External Safety Expert:

• Provide pharmacovigilance (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 Global PV (GPV) teams and 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

Impact:

• 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 from health authorities, ethics committees, IRBs, external partners

• Management of product safety alerts

• Ensuring the GPV position is well articulated to and understood by its internal and external customers

Signal Detection and 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

Impact:

• Signal detection and analysis

• Development of safety action plans and implementation, as appropriate

• Enable effective development of product safety

• Enable appropriate risk management

• Enable up-to-date risk communication (e.g. labeling)

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

Impact:

• Optimization of the product benefit risk profile

• Development of REMS, Risk Management and Development Risk Management plans

• Identification and implementation of risk mitigation or other corrective actions as necessary

• Regulatory compliance

• Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed  

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

Impact:

• Review, data analysis, preparation and/or contribution, and/or update of safety sections of relevant documents:

• For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of Safety, Summary of Clinical Safety, risk management plan, label, periodic reports

• For marketed products: Response to health authority question/request