Vice President Drug Safety

Requirements

• Develop and execute a strategic vision for the drug safety function, aligning with Catalyst’s corporate goals and industry best practices
• Lead PV operations, including collection, evaluation, and analysis of safety data from clinical trials, post-marketing sources, investigator-initiated studies, and real-world evidence
• Oversee the preparation, quality control, and timely submission of expedited and periodic safety reports (e.g., ICSRs, DSURs, PSURs/PBRERs) to health authorities
• Lead 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
• Provide PV subject matter expertise during Health Authority interactions, including inspections, audits, regulatory responses, and scientific advice meetings
• Oversee the development, maintenance, and compliance of PV SOPs, work instructions, and training programs to ensure adherence to regulatory requirements
• Drive inspection readiness efforts in collaboration with Quality and Regulatory teams, ensuring timely, thorough, and compliant responses to regulatory inquiries
• Manage a high-performing team of PV professionals, fostering a culture of excellence, collaboration, and continuous improvement
• Provide executive oversight of safety database infrastructure, MedDRA updates, and system enhancements in partnership with IT and external vendors
• Ensure optimal execution of PV vendor partnerships, establishing service-level agreements, KPIs, and governance frameworks to ensure quality and accountability
• Collaborate cross-functionally with Clinical Development, Regulatory, Medical Affairs, and Commercial to align safety strategy with product development and lifecycle plans
• Contribute to scientific communication efforts, including publications, field training materials, and stakeholder engagement related to safety profiles
• Participate in due diligence, alliance management, and external collaborations as needed, serving as the executive PV representative

Additional Responsibilities

• Executive oversight of implementation of safety technologies
• Contribution to benefit-risk management
• Representation on external 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 success in managing safety surveillance, signal detection, regulatory reporting, and compliance with regulatory requirements, including FDA, EMA, ICH, and GCP
• Deep knowledge of Good Clinical Practice (GCP) and pharmacovigilance regulations and expectations
• Strong clinical judgment with the ability to assess complex safety data and provide clear, evidence-based recommendations
• Excellent organizational and interpersonal skills, with a high degree of leadership credibility, initiative, and the ability to mentor high-performing teams
• Ability to operate effectively in a fast-paced, biotechnology environment, adapting to dynamic priorities and cross-functional demands
• Willingness to travel to company headquarters and other locations as needed to support business operations

Benefits

Catalyst Pharmaceuticals offers competitive wages and comprehensive benefits including health, dental, and vision insurance, generous paid time off, a retirement savings plan with Company Match, and more. Further details about our benefits package can be found here: https://www.linkedin.com/company/catalystforrare/life/life-at-catalyst/?viewAsMember=true