Head of Pharmacovigilance

Praxis

. Build and lead Praxis’s in-house pharmacovigilance function across clinical development and commercial products .

Posted 10/2/2026full-timeRemote • United StatesLead💰 $378,000 - $420,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance, including clinical development and commercial product oversight, with a strong focus on safety strategy, compliance, and regulatory interactions. Proven ability to lead teams, implement quality systems, and manage complex safety-related processes.

Highest-signal resume keywords

Pharmacovigilance LeadershipClinical Trial Safety ManagementRegulatory Compliance ExpertiseSafety Strategy DevelopmentHealth Authority Interactions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceBenefit-Risk AssessmentSignal ManagementSafety ReportingQuality System ImplementationDatabase ValidationIND Safety ReportingICH Guidelines KnowledgeAI Governance in SafetyComplex Case Causality

Soft Skills

Strategic ThinkingCritical JudgmentCommunication SkillsProblem-Solving

Tools & Technologies

AI-Enabled Safety DatabaseSafety Management PlansCompliance Metrics

Certifications & Qualifications

MDDOPhDMPH

Industry Keywords

Pharmacovigilance FunctionPostmarketing SurveillanceClinical DevelopmentFDA InteractionsSafety Governance Body21 CFR ComplianceEU GVP Modules

About the role

Key responsibilities & impact

Build and lead Praxis’s in-house pharmacovigilance function across clinical development and commercial products
Own the pharmacovigilance system, team, quality, governance, and compliance
Lead commercial-product pharmacovigilance, including postmarketing surveillance, reporting, signal management, and benefit-risk
Oversee clinical-development pharmacovigilance through the PV Clinical Development Lead and clinical trial safety team
Make senior medical determinations on benefit-risk, signal adjudication, complex case causality, expectedness, and safety labeling
Approve medical content of PADERs, PBRERs, DSURs, protocols, Investigator’s Brochures, INDs/CTAs, and safety-related documents
Design and stand up the PV operating model and quality system, including SOPs, work instructions, safety management plans, data exchange agreements, deviations, CAPAs, and compliance metrics
Recruit, onboard, develop, and retain the PV team; define competencies, training, and qualification evidence
Bring clinical trial safety activities in-house, including scope, sequencing, validation gates, and vendor exit
Define product and program safety strategies, risk management, and risk mitigation approaches
Chair the Signal Management Committee and ensure signal decisions are documented
Lead FDA and other health-authority safety interactions, information requests, advisory meetings, and inspections
Ensure expedited and periodic reporting compliance and inspection readiness
Govern the AI-enabled safety database, including validation, change control, access, AI governance, human-in-the-loop controls, performance monitoring, and vendor oversight
Provide expert safety guidance and pharmacovigilance training across the organization
Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, Data Science, and Commercial

Requirements

What you’ll need

Physician (MD, DO, or non-US equivalent)
Minimum 12 years of pharmacovigilance experience
Substantive experience in both clinical trial and postmarketing settings
Proven experience building and leading a pharmacovigilance department spanning clinical development and commercial products
Experience personally leading hiring, quality system, database implementation or transition, and inspection preparation
Experience leading through senior direct reports and delegating substantial functional responsibilities
Demonstrated ownership of safety strategy
Demonstrated senior medical judgment, including benefit-risk determination and signal adjudication
Experience chairing or running a safety governance body
Experience with direct health authority interactions on safety matters, including inspections
Working knowledge of IND safety reporting under 21 CFR 312.32 and postmarketing reporting under 21 CFR 314.80
Working knowledge of ICH E2A, E2B(R3), E2D, E2F, E6(R3), EU GVP modules, and 21 CFR Parts 11, 312, and 314
Comfort working with AI in a regulated process and critically evaluating AI-generated narratives, coding, and causality proposals
Excellent oral and written English communication skills
Strategic and critical thinking skills, judgment, and ability to address complex problems across multiple programs
Preferred: clinical practice background in neurology, epilepsy, psychiatry, pediatrics, or rare disease; neuroscience clinical research experience
Preferred: direct accountability for postmarketing pharmacovigilance through a first commercial launch
Preferred: experience transitioning pharmacovigilance activities from outsourced vendor to in-house model
Preferred: experience implementing and validating a safety database, including 21 CFR Part 11 assessment
Preferred: additional advanced degree (PhD or MPH)

Benefits

Comp & perks

99% of medical, dental, and vision premiums paid
Company-paid life insurance
AD&D coverage
Disability benefits
Voluntary insurance plans
Dollar-for-dollar 401(k) match up to 6% of eligible contributions
Long-term stock incentives
Employee Stock Purchase Plan (ESPP)
Discretionary quarterly bonus
Flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns