Sr. Director Drug Safety & Pharmacovigilance (Head)

Sr. Director Drug Safety & Pharmacovigilance (Head of Department)Fully Remote, USACompensation: $265,000-280,000 + bonus + LTI Company Summary:This organization is a well-funded, clinical-stage biotechnology company focused on advancing a broad pipeline across autoimmune and inflammatory diseases. With multiple assets progressing through Phase 2 development and registrational studies on the horizon, the company is entering a critical stage of growth and value inflection. Recent financing has provided a strong capital runway to support late-stage development and continued expansion of the portfolio. Leadership is a key differentiator, with a CEO who has a proven track record of building and successfully exiting biotech companies, alongside a CMO widely recognized for driving multiple blockbuster approvals in the autoimmune space. The organization operates in a highly collaborative, science-driven environment where teams have meaningful ownership and visibility across programs. There is a clear focus on building scalable infrastructure while maintaining a hands-on, execution-focused culture. This is an ideal setting for individuals looking to step into a high-impact role where they can influence strategy, shape processes, and contribute directly to the advancement of clinically meaningful therapies. Responsibilities:Oversee global Safety and Pharmacovigilance activities, ensuring compliance with all regulatory requirements and guidanceLead oversight of adverse event case processing and aggregate safety reporting, ensuring high-quality, timely submissions to regulatory agencies and stakeholdersProvide leadership on safety inputs across clinical and regulatory documents, including protocols, CSRs, investigator brochures, and submissionsPartner closely with Clinical Leads and Medical Monitors to support medical review, safety assessments, and appropriate evaluation of adverse eventsServe as the primary point of contact for internal teams and external partners on all Safety and PV-related mattersLead development and optimization of safety forms, templates, and processes, ensuring alignment with clinical operations across study start-up and executionOversee Safety/PV vendors, ensuring performance, compliance, and high-quality data processing and reportingEnsure effective SAE reconciliation across clinical and safety databasesDrive continuous improvement of PV systems, tools, and processes to support scalability and operational efficiencySupport regulatory interactions, including responses to safety-related inquiries, inspections, and audit findingsContribute to development and maintenance of key safety documents, including core data sheets, labeling, and risk management plansProvide leadership and oversight to safety personnel, supporting performance, development, and a high-performing team environmentPartner cross-functionally across Development, Regulatory, and other functional areas to support integrated program execution Qualifications:M.D. or foreign equivalent5+ years industry experience in Pharmacovigilance