Executive Director, Pharmacovigilance

🕒 Agosto 27

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 18%

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.

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SAB BIO

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2014

🧬 Biotecnologia

💊 Farmacêutico

🏥 Saúde

Biotechnology • Pharmaceuticals • Healthcare

A SAB BIO é uma empresa biofarmacêutica em estágio clínico focada no desenvolvimento de terapias multi-específicas e de alta potência de imunoglobulina G humana (hIgG) para tratar e prevenir distúrbios imunológicos e autoimunes, com a missão declarada de redefinir o diagnóstico e tratamento do diabetes tipo 1 (T1D) através de medicamentos modificadores da doença. Fundada em 2014 e listada na Nasdaq (SABS) desde 2021, a SAB BIO utiliza engenharia genética proprietária e tecnologias de anticorpos para gerar candidatos terapêuticos sem depender de doadores humanos ou plasma convalescente. A empresa realizou sete ensaios clínicos envolvendo cerca de 700 indivíduos em diversas áreas terapêuticas, sem relatos de pacientes com doença do soro ou anticorpos anti-fármacos neutralizantes em seu banco de dados de segurança e imunogenicidade. Seu principal candidato, o SAB-142, visa retardar o início e potencialmente prevenir a progressão do estágio 3 do T1D.

Descrição

• Lead and execute all pharmacovigilance activities for Phase 3 and registrational biologics programs • Ensure compliance with ICH, FDA, EMA, and other applicable regional requirements • Oversee global signal detection, evaluation, management, MedDRA coding review, and benefit-risk assessment updates • Manage safety data receipt, processing, and reporting workflows with CROs, data management, and clinical operations • Serve as subject-matter expert and primary PV contact for clinical, regulatory affairs, and medical affairs teams • Maintain and enforce the global safety database and adverse event reporting infrastructure • Oversee vendor relationships and PV service partnerships • Author or oversee Integrated Safety Summaries (ISS) and Integrated Summaries of Efficacy (ISE) for BLA and MAA submissions • Oversee end-to-end safety labeling strategy for biologics • Lead Clinical Study Report safety sections, including narratives, adverse event tabulations, and laboratory data analyses • Prepare and manage PSURs, PBRERs, and DSURs • Prepare Risk Management Plans and Risk Evaluation and Mitigation Strategies • Respond to health authority safety questions during regulatory reviews • Design and implement systematic pharmacovigilance surveillance programs and safety monitoring plans • Prepare signal assessment reports and escalate findings to the Safety Monitoring Committee or DSMB • Interpret safety trends with clinical pharmacology and biostatistics teams • Support post-marketing commitments and Phase 4 safety studies • Partner with Clinical and Regulatory Affairs on global filing strategy and PV regulatory timelines • Represent PV in Health Authority meetings and advisory committee preparations • Collaborate with Medical Affairs and Commercial teams on labeling updates and post-approval safety activities • Build and mentor a small PV team or oversee contract resources as the company scales • Establish and maintain SOPs, work instructions, and quality standards • Conduct oversight audits and ensure GVP compliance • Represent PV on the Clinical Development Team and participate in Program Team leadership meetings • Travel for team meetings, Health Authority interactions, investigator meetings, and conferences

🎯 Requisitos

• Doctor of Medicine (MD) degree from an accredited institution is required • 12+ years of progressive pharmaceutical/biotech industry pharmacovigilance experience • At least 5 years in a senior role with direct accountability for late-phase global biologics PV programs • Demonstrated hands-on authorship of Integrated Safety Summaries (ISS) submitted in at least one BLA or MAA • Extensive experience authoring CSR safety sections, DSURs, and PSURs/PBRERs for biologic compounds in global development • Deep command of ICH guidelines (E2A–E2E, E6, E8, M4E), FDA/CDER and EMA GVP Module requirements, and regional pharmacovigilance regulations (EU, US, Japan, and other ICH regions) • Extensive experience with signal detection methodologies, benefit-risk assessment frameworks, and safety narrative writing • Proven track record managing CRO/vendor PV relationships and safety database oversight (Argus, ARISg, or equivalent) • Experience with BLA or MAA approval for a biologic • Familiarity with rare disease, orphan drug, or first-in-class biologic programs • Experience presenting to Health Authorities (FDA, EMA) and participation in Advisory Committee proceedings • Familiarity with REMS design and implementation or EU RMP preparation • Knowledge of pharmacoepidemiology methodologies and real-world evidence applications in safety assessment • Exceptional scientific and medical writing ability • Strong analytical and critical thinking skills • Ability to independently evaluate complex safety signals and formulate evidence-based recommendations • Ability to engage clinical, statistical, and regulatory colleagues at a peer level • Excellent project management skills • Demonstrated leadership and cross-functional collaboration • Comfortable operating with limited infrastructure and high personal accountability • Regularly required to walk, stand, and sit • Must regularly lift and/or move up to 10 pounds

🏖️ Benefícios

• Home office working environment • Domestic and international business travel (estimated 10–20%) • Reasonable accommodations in compliance with the Americans with Disabilities Act of 1990 • Equal employment opportunity protections • SMS/text message updates regarding the job application