Medical Director, Pharmacovigilance

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee all pre- and post-marketing safety surveillance activities throughout the product lifecycle, ensuring compliance with ICH guidelines, FDA, EMA, and applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP).

• Lead and contribute to the global safety strategy, ensuring the review and assessment of pre-clinical, clinical, and post-marketing safety data to maintain a favorable benefit-risk profile for Allogenic CAR T therapy in collaboration with key stakeholders.

• Work alongside various functional teams, including but not limited to Biostatistics, Clinical, Translational Sciences, Research, and Regulatory Affairs, to identify, evaluate, comprehend, and develop risk management strategies for safety signals.

• Provide clinical safety support and input for clinical development initiatives.

• Engage in authoring relevant safety sections of clinical protocols, Investigator's Brochure (IB), informed consent forms (ICF), statistical analysis plans, study reports, and other clinical study-related documents to ensure alignment with the safety strategy and risk communication.

• Contribute to the creation of safety-related data collection standards for clinical studies to ensure uniformity in safety data collection.

• Collaborate on strategy development and author responses to health authority and other safety-related inquiries.

• Take the lead in developing, implementing, and maintaining robust procedures for the planning, preparation, and submission of high-quality safety reports.

• Conduct medical reviews of individual case safety reports (ICSRs) promptly to ensure timely submission to regulatory authorities.

• Demonstrate knowledge and ensure compliance with current and applicable global pharmacovigilance regulations (e.g., CIOMS, EMA, FDA, ICH).

• Perform additional duties as assigned.

⛳️ Requirements

• A medical degree (MD) with a solid clinical background and a minimum of 3 years of relevant industry experience.

• Experience in clinical practice or clinical research is preferred.

• A strong preference for experience in oncology and/or cell therapy.

• Comprehensive understanding of pharmacovigilance principles, global regulatory requirements, and MedDRA coding.

• Experience in signal detection, evaluation, aggregate data analysis, and interpretation within clinical trials.

• Must possess proficiency in Argus.

• Excellent analytical and critical thinking skills for evaluating complex medical data.

• Strong communication and collaboration skills for effective interaction with cross-functional teams.

• Outstanding organizational skills and the ability to prioritize effectively to deliver results within tight timelines, demonstrating the capability to work independently as well as part of a team.

• Ability to communicate with both internal and external physicians to assess specific safety events.

• Candidates must be authorized to work in the U.S.

🏝️ Benefits

• Annual performance bonus

• Equity

• Health insurance

• Generous time off, including two annual holiday company-wide shutdowns