Senior Director, Head of Drug Safety and Pharmacovigilance

Job Description: • Develop and execute the global pharmacovigilance strategy to align with company goals and evolving regulatory requirements • Ensure the company complies with all global drug safety and reporting regulations (e.g., FDA, EMA, ICH) and implement necessary process updates. • Lead, manage, and develop the pharmacovigilance team, fostering a culture of continuous improvement. • Work closely with both internal and external stakeholders, including but not limited to Clinica Development, Regulatory Affairs, Quality Assurance, and Medical Affairs, to provide integrated safety oversight and ensure effective and timely monitoring, oversight, communication, and risk mitigation of emerging safety signals • Lead safety and pharmacovigilance activities for all company products marketed and in development including ICSR review, periodic safety surveillance activities, safety issue work-up, preparation o DSUR, PADER, PBRER, etc. and authoring relevant safety sections of clinical documents including protocols, IB, ICFs, CSR etc • Provide oversight of safety vendors to ensure all pharmacovigilance commitments are delivered and timelines are followed and manages the budget for these activities • Evaluate and interpret safety data from pre-clinical studies, clinical studies, literature, and post-marketing information etc. to develop safety profile of company products • Provide benefit/risk assessment on potential safety signals as needed • Lead internal Safety Review Committees for all company products, and lead the identification and assessment of safety signals and development of action plans as needed • Work with vendors to prepare/review all safety relevant operational documents, including SMP, SAE reconciliation plan, medical monitoring plan, data management plan etc. • Collaborate with business partners on development of PVAs and ensures compliance with PVAs • Provide safety related due diligence for business development opportunities. • Support/Lead development of pharmacovigilance plans / risk management strategies etc. • Establish department structure, processes, and procedures, responsible for hiring / training new employees • Collaborate with QA for audit and inspection readiness Requirements: • Degree in life sciences, medicine, or pharmacology required (for example, RN, PharmD, or MD) • 15+ years of industry experience in safety and pharmacovigilance including increasing responsibility in administrative and management roles • Expertise in safety signal detection and management, clinical safety assessments of individual cases and aggregate data, case processing and routine pharmacovigilance practices, including interactions with Regulatory Authorities • Expert knowledge and familiarity with FDA regulations, EU GVP and ICH standards for development and marketing of pharmaceutical products, Good Clinical Practice (GCP) requirements, and other applicable regulatory standards • Clinical experience strongly preferred • Proven ability to manage cross-functional collaborations, lead discussions on safety strategy, and resolve complex patient safety concerns. • Skilled in translating safety data into clear, actionable insights and communicating effectively across internal teams, leadership, and regulatory authorities. • A “can do” attitude and ability to operate in a fast-paced startup environment Benefits: • A discretionary annual bonus may be available based on individual and Company performance