Vice President Drug Safety chez Catalyst Pharmaceuticals Inc

Description

The Vice President (VP) of Drug Safety will lead drug safety operations across Catalyst’s development and commercial portfolio, overseeing PV infrastructure, case management systems, vendor oversight, 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. The VP manages a multidisciplinary  PV operations team, including internal PV specialists and external vendors/partners.  The VP,  PV also partners cross-functionally with Clinical Development, Regulatory Affairs, Medical  Affairs, Quality, Legal, and Commercial to enable efficient and compliant safety oversight  across all programs. The VP, PV is also responsible for regular periodic regulatory updates and  reports, along with spontaneous reporting as necessary and indicated.    

Requirements

Responsibilities (included but not limited to): 

• 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 include executive oversight of implementation of safety technologies, contribution to benefit-risk management, and representation on external

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, 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 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

Catalyst is committed to providing 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

The base salary for this position will range from $380,000 to $400,000. Candidate experience, professional licensing, and geographic location will be taken into consideration. 

EEO Statement

Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status. 

Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.