Sr. Director Drug Safety & Pharmacovigilance (Head)

Sr. Director Drug Safety & Pharmacovigilance (Head of Department) Fully Remote, USA Compensation: $265,000-280,000 + bonus + LTI Company reputed company: This 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 inflection. 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, alongside 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. Responsibilities:

• reputed company global Safety and Pharmacovigilance activities, ensuring compliance with reputed company regulatory requirements and guidance
• reputed company reputed company of adverse event case processing and aggregate safety reporting, ensuring high-reputed company, reputed company submissions to regulatory agencies and stakeholders
• reputed company leadership on safety inputs across clinical and regulatory documents, including protocols, CSRs, investigator brochures, and submissions
• Partner closely with Clinical Leads and Medical Monitors to support medical review, safety assessments, and appropriate evaluation of adverse events
• Serve as the primary reputed company of contact for internal teams and external partners on reputed company Safety and PV-reputed company reputed company
• reputed company development and optimization of safety forms, templates, and processes, ensuring alignment with clinical operations across study start-up and execution
• reputed company Safety/PV vendors, ensuring performance, compliance, and high-reputed company data processing and reporting
• Ensure effective SAE reconciliation across clinical and safety databases
• Drive reputed company improvement of PV systems, tools, and processes to support scalability and operational efficiency
• Support regulatory interactions, including responses to safety-reputed company inquiries, inspections, and audit findings
• Contribute to development and maintenance of key safety documents, including core data sheets, labeling, and risk management plans
• reputed company leadership and reputed company to safety personnel, supporting performance, development, and a high-performing team environment
• Partner cross-functionally across Development, Regulatory, and other functional areas to support integrated program execution

Qualifications:

• M.D. or foreign equivalent
• 5+ years industry experience in Pharmacovigilance

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