Medical Director, Pharmacovigilance

About the role

The Medical Director, Pharmacovigilance serves as the safety expert accountable for the global safety strategy and overall safety profile throughout a product’s lifecycle. This includes leading all major pre- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities. You will help develop and lead surveillance activities and provide scientific/clinical/pharmacovigilance expertise for safety data analysis from various sources including pre-clinical studies, clinical studies, literature and other information sources. You will focus on the proactive identification, evaluation, and risk management of safety risks to patients.

Responsibilities

• Manage all pre- and post-marketing safety surveillance activities throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigance Practices (GVP)
• Lead and provide input to global safety strategy ensuring review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for Allogene CAR T therapy in collaboration with essential stakeholders
• Collaborate with other functional areas, including but not limited to Biostatistics, Clinical, Translational Sciences, Research and Regulatory Affairs to identify, evaluate, understand and develop risk management strategies for safety signals
• Provide clinical safety support and input for clinical development programs
• Participate in the authoring of relevant safety sections of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF), statistical analysis plans, study reports and other clinical study-related documents to ensure alignment with the safety strategy and risk communication
• Participate in the development of safety-related data collection standards for clinical studies to ensure consistency in safety data collection
• Collaborate on the strategy and authoring of health authority and other safety related query responses
• Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
• Medical review of individual case safety reports (ICSRs) in a timely manner to ensure on time submission to regulatory authorities
• Demonstrate knowledge and ensure compliance with current and applicable global PV regulations (e.g., CIOMS, EMA, FDA, ICH)

Position Requirements & Experience

• Medical degree (MD) with a strong clinical background, with at least 3 of relevant years industry experience
• Experience in clinical practice or clinical research is preferred
• Experience in oncology and/or cell therapy is strongly preferred
• Thorough understanding of pharmacovigilance principles, global regulatory requirements, and MedDRA coding
• Experience in signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials
• Must be proficient in Argus
• Excellent analytical and critical thinking skills to evaluate complex medical data
• Strong communication and collaboration skills to effectively interact with cross-functional teams
• Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
• Ability to communicate with internal and external physicians to evaluate specific safety events
• Candidates must be authorized to work in the U.S