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Vice President, Drug Safety
Catalyst Pharmaceuticals, Inc.Vice President of Drug Safety leading drug safety operations at Catalyst Pharmaceuticals. Managing a multidisciplinary team and ensuring compliance with regulatory requirements while working remotely.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
- Provide strategic and operational leadership for the design and execution of drug safety capabilities
- Manage a multidisciplinary PV operations team, including internal PV specialists and external vendors/partners
- Partner cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Legal, and Commercial to enable efficient and compliant safety oversight across all programs
- Responsible for regular periodic regulatory updates and reports, along with spontaneous reporting as necessary and indicated
- Develop and execute a strategic vision for the drug safety function, aligning with Catalyst’s corporate goals and industry best practices
- Oversee the preparation, quality control, and timely submission of expedited and periodic safety reports to health authorities
- Manage a high-performing team of PV professionals, fostering a culture of excellence, collaboration, and continuous improvement
- Ensure optimal execution of PV vendor partnerships, establishing service-level agreements, KPIs, and governance frameworks to ensure quality and accountability
Requirements
What you’ll need- 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
- Willingness to travel to company headquarters and other locations as needed to support business operations.
Benefits
Comp & perks- health, dental, and vision insurance
- generous paid time off
- retirement savings plan with Company Match
- competitive wages
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
PharmacovigilanceSafety ReportingSignal DetectionRegulatory ReportingAdverse Event ReportingClinical DevelopmentPost-Marketing SafetySafety Lifecycle ManagementTherapeutic ExperienceLeadership in Drug Safety
Soft Skills
Organizational SkillsInterpersonal SkillsLeadership CredibilityMentoringInitiative
Certifications
MD in Relevant Clinical/Scientific Field