Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Drug Safety Physician based in United States. This is a senior medical safety leadership role within a dynamic clinical-stage biotechnology environment. You will help shape drug safety strategy across an innovative portfolio of antibody-based therapies in immunology. The role spans individual case safety review, aggregate safety monitoring, signal detection, surveillance, and benefit-risk management. You will partner with cross-functional teams to ensure safety considerations are integrated throughout clinical development. The position also provides opportunities to engage with global regulatory requirements, health authority interactions, and clinical trial documentation. You will contribute to evolving pharmacovigilance processes while helping establish consistent, high-quality approaches to medical safety review. This fully remote opportunity offers frequent in-person collaboration, professional development, and a competitive salary range of $280,000–$311,000. Accountabilities: As Director, Drug Safety Physician, you will provide medical expertise across drug safety and pharmacovigilance activities, supporting assigned development programs from ongoing safety review through regulatory interactions and benefit-risk management. You will work closely with medical, clinical, and cross-functional colleagues to ensure safety activities are timely, accurate, scientifically rigorous, and aligned with global requirements. - Perform triage and medical review of Individual Case Safety Reports (ICSRs), both within and outside the global safety database. - Oversee cases and Analysis of Similar Events (AOSEs) supporting expedited safety reporting. - Lead cross-functional medical review discussions related to ICSR assessment. - Participate in preparing, writing, and reviewing aggregate safety reports, including DSURs. - Review safety sections of clinical trial documents and regulatory submissions.

- Lead or contribute to scientific literature reviews and prepare written summaries supporting aggregate safety analyses. - Participate in safety surveillance activities and evaluate emerging safety signals from multiple data sources. - Support the assessment, management, and monitoring of identified safety signals. - Participate in and co-present cases at Safety Management Team and Safety Review Team meetings. - Co-lead safety surveillance and signal management meetings. - Develop safety presentations for independent Data Monitoring Committee meetings. - Provide medical safety input into clinical development plans, study protocols, periodic safety reports, and safety management plans. - Provide safety strategy and execution support for benefit-risk management of assigned products. - Contribute to responses to health authority, institutional review board, and ethics committee queries. - Support the development of safety risk language, risk management strategies, safety table shells, and integrated safety reviews. - Contribute to integrated safety summary documents and safety-focused publications. - Lead epidemiology and pharmacoepidemiology projects relevant to drug safety and pharmacovigilance, including natural history, comorbidities, class effects, real-world safety, signal detection, data mining, and comparative safety research. - Collaborate with the Medical Review Lead and other physicians to establish consistent approaches to medical review, safety presentations, and surveillance activities. - Assist with the development and maintenance of pharmacovigilance processes, SOPs, work instructions, safety management plans, and surveillance plans. - Identify and implement process improvements across medical review, safety surveillance, and relevant pharmacovigilance activities.

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