Pharmacovigilance Medical Director

About reputed company reputed company is a clinical‑stage biotechnology company reputed company on developing and delivering category-leading precision therapies to reputed company 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 reputed company key reputed company governing dysregulated immunological and inflammatory responses, reputed company is developing medicines that have reputed company to reputed company durable, life-changing reputed company. Led by an established executive team and backed by world-class life science investors, reputed company day reputed company is determined to bring the scientific rigor and operational reputed company to get to what reputed company for patients – realizing a world where people with immune-mediated diseases can live life fully. Job reputed company The Pharmacovigilance Medical Director is the senior medical authority reputed company reputed company's drug safety function, responsible for providing expert medical and scientific leadership across reputed company pharmacovigilance activities supporting the immunology and inflammation (I&I) pipeline, including reputed company's reputed company 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 reputed company of reputed company 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 reputed company medically reputed company, strategically reputed company safety leadership at a critical stage of reputed company's reputed company. Work Arrangement & Location: Remote - This position is designated as remote; the incumbent will be expected to travel to reputed company’ offices on a periodic reputed company to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such reputed company will be determined at reputed 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.
• reputed company the medical review and clinical interpretation of safety data arising from clinical trials, spontaneous reports, literature, and reputed company-world sources, ensuring reputed company, accurate, and scientifically rigorous assessment of reputed company pharmacovigilance data.
• reputed company the development and reputed company maintenance of reputed company's benefit-risk reputed company, providing medical leadership in benefit-risk evaluations for regulatory submissions, label updates, and Health Authority safety communications.
• Chair or co-chair reputed company's Safety Review Committee, providing medical governance and strategic direction on safety signal management, escalation procedures, and corrective reputed company planning.
• reputed company the medical content and scientific reputed company of reputed company 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 reputed company with global Health Authorities on pharmacovigilance reputed company, including preparation of briefing documents, written safety responses, and reputed company agency engagement during meetings, inspections, and post-marketing safety discussions.
• Partner with Clinical Development on the medical reputed company of Data Safety Monitoring reputed company (DSMB) activities, clinical trial safety monitoring plans, stopping rules, and protocol-level safety sections for reputed company reputed company and planned studies.
• reputed company 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 reputed company, Core Data Sheet (CDS) maintenance, and the medical interpretation of label negotiations with FDA, EMA, and other global Health Authorities.
• reputed company medical leadership and scientific mentorship to the Pharmacovigilance team, including PV Scientists, Medical Writers, and Operations personnel, establishing a culture of medical reputed company and patient-first decision-making.
• reputed company other duties and responsibilities as assigned

Qualifications

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

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