Medical Director, Pharmacovigilance

🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

💵 $255k - $335k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Allogene Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Allogene Therapeutics is a clinical-stage biotechnology company headquartered in South San Francisco developing allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer and autoimmune diseases. The company focuses on immunotherapy and oncology, leveraging off-the-shelf CAR T approaches to create allogeneic cell therapy products targeting hematologic malignancies and potentially autoimmune indications.

📋 Description

• 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 Pharmacovigilance 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 Allogenic 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) • Other duties as assigned

🎯 Requirements

• 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

🏖️ Benefits

• annual performance bonus • equity • health insurance • generous time off (including 2 annual holiday company-wide shutdowns)