Pharmacovigilance Medical Director

About Beeline Medicines Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. Job Summary The Pharmacovigilance Medical Director is the senior medical authority within the company's drug safety function, responsible for providing expert medical and scientific leadership across all pharmacovigilance activities supporting the immunology and inflammation (I&I) pipeline, including the company's lead lupus program. This role serves as the primary physician voice for benefit-risk evaluation, signal assessment, and safety governance, ensuring that patient safety is upheld as the foundational principle of all clinical development and post-market activities. The Medical Director partners closely with the Head of Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs, and external Health Authorities to provide medically sound, strategically aligned safety leadership at a critical stage of the company's growth. Work Arrangement & Location: Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need. Essential Duties And Responsibilities

• Serve as the senior medical expert and physician-of-record for pharmacovigilance activities, providing authoritative medical judgment on individual case safety reports (ICSRs), aggregate safety analyses, signal evaluations, and benefit-risk assessments across the I&I portfolio.
• Lead the medical review and clinical interpretation of safety data arising from clinical trials, spontaneous reports, literature, and real-world sources, ensuring timely, accurate, and scientifically rigorous assessment of all pharmacovigilance data.
• Direct the development and continuous maintenance of the company's benefit-risk framework, providing medical leadership in benefit-risk evaluations for regulatory submissions, label updates, and Health Authority safety communications.
• Chair or co-chair the company's Safety Review Committee, providing medical governance and strategic direction on safety signal management, escalation procedures, and corrective action planning.
• Oversee the medical content and scientific quality of all aggregate safety reports, including Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs/PSURs), and Integrated Summaries of Safety (ISS) for NDA/BLA submissions.
• Serve as the primary medical interface with global Health Authorities on pharmacovigilance matters, including preparation of briefing documents, written safety responses, and direct agency engagement during meetings, inspections, and post-marketing safety discussions.
• Partner with Clinical Development on the medical oversight of Data Safety Monitoring Board (DSMB) activities, clinical trial safety monitoring plans, stopping rules, and protocol-level safety sections for all active and planned studies.
• Provide expert medical input to Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and risk minimization measure design, execution, and effectiveness assessment.
• Collaborate with Regulatory Affairs on safety labeling strategy, Core Data Sheet (CDS) maintenance, and the medical interpretation of label negotiations with FDA, EMA, and other global Health Authorities.
• Provide medical leadership and scientific mentorship to the Pharmacovigilance team, including PV Scientists, Medical Writers, and Operations personnel, establishing a culture of medical excellence and patient-first decision-making.
• Perform other duties and responsibilities as assigned

Qualifications

• Education: Medical degree (MD or DO) required; board certification or eligibility in immunology, rheumatology, nephrology, internal medicine, or a relevant specialty with direct patient care experience in

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