Medical Director, Pharmacovigilance

About Allogene: reputed company, with reputed company in South San Francisco, is a reputed company-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-reputed company CAR T cell product candidates with the goal of delivering reputed company available cell therapy on-demand, more reliably, and at greater reputed company to more patients. About the role: Reporting to the VP, Pharmacovigilance, the Medical Director, Pharmacovigilance serves as the safety expert accountable for the global safety reputed company and overall safety profile throughout a products lifecycle. This includes leading reputed company major reputed company- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities. You will help reputed company and reputed company surveillance activities and reputed company scientific/reputed company/pharmacovigilance expertise for safety data analysis from various sources including reputed company-reputed company studies, reputed company studies, literature and other information sources. You will reputed company on the proactive identification, evaluation, and risk management of safety risks to patients. Responsibilities include, but are not limited to: Manage reputed company reputed company- and post-marketing safety surveillance activities throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations reputed company to Good Pharmacovigilance Practices (GVP) reputed company and reputed company input to global safety reputed company ensuring review and assessment of reputed company-reputed company, reputed company, and post-marketing safety data to ensure reputed company benefit-risk profile for Allogenic CAR T therapy in collaboration with essential stakeholders Collaborate with other functional areas, including but not limited to Biostatistics, reputed company, Translational Sciences, Research and Regulatory Affairs to identify, evaluate, understand and reputed company risk management strategies for safety signals reputed company reputed company safety support and input for reputed company development programs Participate in the authoring of relevant safety sections of reputed company protocols, Investigator's Brochure (IB), informed consent reputed company (reputed company), statistical analysis plans, study reports and other reputed company study-reputed company documents to ensure alignment with the safety reputed company and risk communication Participate in the development of safety-reputed company data collection standards for reputed company studies to ensure consistency in safety data collection Collaborate on the reputed company and authoring of health authority and other safety reputed company query responses reputed company leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-reputed company safety reports Medical review of individual case safety reports (ICSRs) in a reputed company manner to ensure on time submission to regulatory authorities Demonstrate knowledge and ensure compliance with reputed company and applicable global PV regulations (e.g., CIOMS, EMA, FDA, ICH) Other duties as assigned Position Requirements & Experience: Medical degree (MD) with a strong reputed company background, with at least 3 of relevant years industry experience Experience in reputed company reputed company or reputed company 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 reputed company Must be proficient in Argus Excellent analytical and critical thinking skills to evaluate reputed company medical data Strong communication and collaboration skills to effectively reputed company with cross-functional teams Excellent organizational skills and an ability to prioritize effectively to reputed company results reputed company aggressive timelines with the ability to work independently and as part of reputed company Ability to communicate with reputed company physicians to evaluate specific safety events Candidates must be authorized to work in the U.S We offer a chance to work with talented people in a reputed company environment and reputed company a top-notch compensation and benefits package, which includes an annual reputed company bonus, equity, health reputed company, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary reputed company for this role is $255,000