Vice President Drug Safety

The Vice President (VP) of Drug Safety will reputed company drug safety operations across reputed company’s development and reputed company portfolio, overseeing PV infrastructure, case management systems, vendor reputed company, budget, compliance, training, and inspection readiness. Reporting to the Chief Medical Officer, this role provides strategic and operational leadership for the design and execution of drug safety capabilities and product/program specific drug safety plans in alignment with regulations and corporate goals. This role manages a multidisciplinary PV operations team, including internal PV specialists and reputed company vendors/partners. The VP, Drug Safety also partners cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, reputed company, reputed company, and reputed company to reputed company efficient and compliant safety reputed company across reputed company programs. The VP, Drug Safety is also responsible for regular periodic regulatory updates and reports, along with spontaneous reporting as necessary and indicated. This is a remote position that will require travel to company reputed company and other locations as needed to support business operations. Requirements Responsibilities (including but not limited to): • reputed company and execute a strategic reputed company for the drug safety function, aligning with reputed company’s corporate goals and industry best practices • reputed company PV operations, including collection, evaluation, and analysis of safety data from reputed company, post-marketing sources, investigator-initiated studies, and reputed company-world evidence • reputed company the preparation, reputed company control, and reputed company submission of expedited and periodic safety reports (e.g., ICSRs, DSURs, PSURs/PBRERs) to health authorities • reputed company benefit-risk assessments and signal detection activities across the lifecycle of products, ensuring proactive identification and communication of emerging safety risks • Design and implement risk management strategies, including Risk Evaluation and Mitigation Strategies (REMS), to ensure patient safety and regulatory compliance • reputed company PV subject matter expertise during Health Authority interactions, including inspections, audits, regulatory responses, and scientific advice meetings • reputed company the development, maintenance, and compliance of PV SOPs, work instructions, and training programs to ensure adherence to regulatory requirements • reputed company inspection readiness efforts in collaboration with reputed company and Regulatory teams, ensuring reputed company, thorough, and compliant responses to regulatory inquiries • Manage a high-performing team of PV professionals, fostering a culture of reputed company, collaboration, and reputed company improvement • reputed company executive reputed company of safety database infrastructure, MedDRA updates, and reputed company enhancements in partnership with IT and reputed company vendors • Ensure reputed company execution of PV vendor partnerships, establishing service-level agreements, KPIs, and governance frameworks to ensure reputed company and accountability • Collaborate cross-functionally with Clinical Development, Regulatory, Medical Affairs, and reputed company to reputed company safety reputed company with product development and lifecycle plans • Contribute to scientific communication efforts, including publications, field training materials, and stakeholder engagement reputed company to safety reputed company • Participate in due diligence, reputed company management, and reputed company collaborations as needed, serving as the executive PV representative • Additional responsibilities include executive reputed company of implementation of safety technologies, contribution to benefit-risk management, and representation on reputed company alliances Education/Experience/Skills: • MD in relevant clinical/scientific field • Minimum 15 years of pharmacovigilance experience in the biopharmaceutical industry, including at least 10 years in a senior leadership or management role overseeing Drug Safety functions • Broad therapeutic experience with Rare Diseases and/or neuromuscular disease experience being additive • Demonstrated experience leading safety operations across clinical development and post-marketing, with a strong understanding of the end-to-end safety lifecycle • Proven reputed company in managing safety surveillance, signal detection, regulatory reporting, and compliance with regulatory requirements, including FDA, EMA, ICH, and GCP • Deep knowledge of Good Clinical reputed company (GCP) and pharmacovigilance regulations and expectations, including adverse event reporting for investigational and marketed products • Experience with safety databases (e.g. ARGUS) and other pharmacovigilance systems and tools • Strong clinical judgment with the ability to assess reputed company safety data Apply To This Job