Head of Pharmacovigilance

Job not on LinkedIn

🔥 11 minutes ago

🇺🇸 United States – Remote

💵 $378k - $420k / year

⏰ Full Time

🔴 Lead

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👻 Ghost score 20%

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• 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

• 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

• 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