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.

Posted 7/7/2026full-time🇺🇸 United StatesLead💰 $405,000 - $430,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance and drug safety operations, with a strong focus on regulatory compliance, safety reporting, and team leadership. Proven ability to manage cross-functional partnerships and drive strategic initiatives in a fast-paced biotechnology environment.

Highest-signal resume keywords

Pharmacovigilance ExperienceDrug Safety LeadershipRegulatory ComplianceSafety Surveillance ManagementGCP Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceSafety ReportingSignal DetectionRegulatory ReportingAdverse Event ReportingClinical DevelopmentPost-Marketing SafetySafety Lifecycle ManagementTherapeutic ExperienceLeadership in Drug Safety

Soft Skills

Organizational SkillsInterpersonal SkillsLeadership CredibilityMentoringInitiative

Tools & Technologies

ARGUSSafety DatabasesPharmacovigilance Systems

Certifications & Qualifications

MD in Relevant Clinical/Scientific Field

Industry Keywords

Biopharmaceutical IndustryRare DiseasesNeuromuscular DiseaseFDAEMAICHGCPComplianceQuality ControlVendor Oversight

Tech Stack

Tools & technologies

Google 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