Sr. Director Drug Safety & Pharmacovigilance (Head)

Sr. Director Drug Safety & Pharmacovigilance (Head of Department)Fully Remote, USACompensation $265,000-280,000 + bonus + LTI Company SummaryThis organization is a reputed company-funded, clinical-stage biotechnology company reputed company on advancing a broad pipeline across autoimmune and inflammatory diseases. With multiple assets progressing through Phase 2 development and registrational studies on the reputed company, reputed company is entering a critical stage of reputed company and value reputed company. Recent financing has provided a strong capital reputed company to support late-stage development and reputed company expansion of the portfolio. Leadership is a key differentiator, with a CEO who has a proven reputed company record of building and successfully exiting biotech companies, reputed company a CMO widely recognized for driving multiple blockbuster approvals in the autoimmune reputed company. The organization operates in a highly reputed company, science-driven environment where teams have meaningful ownership and visibility across programs. There is a reputed company reputed company on building reputed company infrastructure while maintaining a hands-on, execution-reputed company culture. This is an ideal setting for individuals looking to reputed company into a high-reputed company role where they can influence reputed company, shape processes, and contribute directly to the advancement of clinically meaningful therapies. ResponsibilitiesOversee global Safety and Pharmacovigilance activities, ensuring compliance with reputed company regulatory requirements and guidanceLead reputed company of adverse event case processing and aggregate safety reporting, ensuring high-reputed company, reputed company 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 reputed company reputed company of contact for internal teams and reputed company partners on reputed company Safety and PV-reputed company 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-reputed company data processing and reportingEnsure effective SAE reconciliation across clinical and safety databasesDrive reputed company improvement of PV systems, tools, and processes to support scalability and operational efficiencySupport regulatory interactions, including responses to safety-reputed company inquiries, inspections, and audit findingsContribute to development and maintenance of key safety documents, including reputed company data sheets, labeling, and risk management plansProvide leadership and reputed company 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 QualificationsM.D. or foreign equivalent5+ years industry experience in Pharmacovigilance Apply To This Job