Head of Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish and manage the in-house pharmacovigilance function for Praxis, covering both clinical development and commercial products.

• Take ownership of the pharmacovigilance system, including team dynamics, quality assurance, governance, and compliance.

• Lead the pharmacovigilance efforts for commercial products, encompassing postmarketing surveillance, reporting, signal management, and benefit-risk analysis.

• Supervise clinical development pharmacovigilance through the PV Clinical Development Lead and the clinical trial safety team.

• Make high-level medical decisions regarding benefit-risk, signal adjudication, complex case causality, expectedness, and safety labeling.

• Validate the medical content of PADERs, PBRERs, DSURs, study protocols, Investigator’s Brochures, INDs/CTAs, and safety-related documents.

• Design and implement the pharmacovigilance operating model and quality system, which includes SOPs, work instructions, safety management plans, data exchange agreements, deviations, CAPAs, and compliance metrics.

• Recruit, onboard, develop, and retain the pharmacovigilance team; establish competencies, training, and qualification criteria.

• Integrate clinical trial safety activities in-house, including defining scope, sequencing, validation gates, and vendor exit strategies.

• Define safety strategies, risk management, and risk mitigation approaches for products and programs.

• Chair the Signal Management Committee, ensuring that signal decisions are properly documented.

• Lead safety interactions with the FDA and other health authorities, including information requests, advisory meetings, and inspections.

• Ensure compliance with expedited and periodic reporting and maintain inspection readiness.

• Oversee the AI-enabled safety database, focusing on validation, change control, access, AI governance, human-in-the-loop controls, performance monitoring, and vendor oversight.

• Provide expert safety guidance and pharmacovigilance training throughout the organization.

• Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, Data Science, and Commercial teams.

⛳️ Requirements

• Medical Doctor (MD, DO, or non-US equivalent).

• At least 12 years of experience in pharmacovigilance.

• Significant experience in both clinical trial and postmarketing environments.

• Proven track record in building and leading a pharmacovigilance department that encompasses clinical development and commercial products.

• Experience in leading hiring initiatives, managing quality systems, implementing or transitioning databases, and preparing for inspections.

• Demonstrated ability to lead through senior direct reports and delegate significant functional responsibilities.

• Proven ownership of safety strategy.

• Demonstrated senior medical judgment, including benefit-risk assessment and signal adjudication.

• Experience in chairing or managing a safety governance body.

• Familiarity with direct interactions with health authorities regarding safety matters, including inspections.

• Knowledge of IND safety reporting under 21 CFR 312.32 and postmarketing reporting under 21 CFR 314.80.

• Understanding of ICH E2A, E2B(R3), E2D, E2F, E6(R3), EU GVP modules, and 21 CFR Parts 11, 312, and 314.

• Comfortable using AI in a regulated environment, with the ability to critically evaluate AI-generated narratives, coding, and causality proposals.

• Exceptional oral and written communication skills in English.

• Strong strategic and critical thinking abilities, judgment, and aptitude for addressing complex problems across various programs.

• Preferred: clinical practice experience in neurology, epilepsy, psychiatry, pediatrics, or rare diseases; experience in neuroscience clinical research.

• Preferred: direct responsibility for postmarketing pharmacovigilance during a first commercial launch.

• Preferred: experience transitioning pharmacovigilance activities from outsourced vendors to an in-house model.

• Preferred: experience in implementing and validating a safety database, including assessment of compliance with 21 CFR Part 11.

• Preferred: possession of an additional advanced degree (PhD or MPH).

🏝️ Benefits

• 99% of medical, dental, and vision premiums covered.

• Company-funded life insurance.

• AD&D coverage included.

• Disability benefits offered.

• Options for voluntary insurance plans.

• Dollar-for-dollar 401(k) match up to 6% of eligible contributions.

• Long-term stock incentives available.

• Employee Stock Purchase Plan (ESPP) provided.

• Discretionary quarterly bonuses.

• Flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays included.

• Company-wide shutdowns observed.