Head of Pharmacovigilance

Vaga não está no LinkedIn

🕒 Outubro 2

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $378.000 - $420.000 / ano

⏰ Tempo Integral

🔴 Especialista

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 20%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Praxis

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2002

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Praxis é uma empresa dedicada a conectar pacientes com oportunidades significativas de ensaios clínicos. Com foco na criação de programas de recrutamento personalizados, a Praxis utiliza uma variedade de ferramentas especializadas e vasta experiência em diversas áreas terapêuticas para garantir que alcancem os pacientes certos em todo o mundo. Estabelecida em 2002, a empresa enfatiza a importância do engajamento do paciente e utiliza insights sofisticados de dados para aprimorar a jornada do paciente na pesquisa clínica.

Descrição

• 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

🎯 Requisitos

• 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)

🏖️ Benefícios

• 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