Senior Director, Pharmacovigilance Operations – Compliance

🕒 Outubro 13

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $270.000 - $370.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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• Aberta há 28 dias.
• As vagas desta empresa costumam ser preenchidas em 71 dias.

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Vera Therapeutics, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico focada no desenvolvimento de tratamentos para doenças renais imunológicas que melhorem a vida dos pacientes. A empresa está avançando com o Atacicept através do desenvolvimento clínico para nefropatia por IgA (IgAN), conduzindo testes de Fase 2b e Fase 3, e perseguindo programas em nefrite lúpica e outras condições imunológicas. Com sede em Brisbane, CA, a Vera enfatiza o desenvolvimento de medicamentos orientado pela ciência, o engajamento com os pacientes e a sustentabilidade.

Descrição

• Create, direct, and manage the company’s pharmacovigilance operations and compliance infrastructure and staff • Own and drive global PV Operations strategy, planning, implementation, and management • Advise the Head of DSPV on operational risk, resource allocation, and budget planning • Own the DSPV Operations budget, including CRO and vendor contract spend • Represent DSPV Operations to senior leadership and external partners • Manage internal and external staff and own talent strategy, hiring, development, performance management, and succession planning • Build and implement globally compliant pharmacovigilance systems • Oversee safety systems, MedDRA updates, PV vendors, quality metrics, invoicing, and budgets • Develop and implement inspection readiness programs and lead PV Operations during FDA, EMA, and MHRA inspections and audits • Oversee compliant case management and timely expedited safety report submissions • Establish systems for identifying, preventing, and correcting compliance deviations and implementing CAPAs • Set up safety projects, Safety Management Plans, safety systems, and PV database configurations • Draft and implement PV SOPs and work instructions • Contribute to signal detection, benefit-risk assessment, and aggregate reporting • Collaborate with Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs, and Manufacturing • Represent PV Operations on project teams, committees, and governance bodies • Lead training and training compliance activities • Build and oversee PV regulatory intelligence activities

🎯 Requisitos

• Healthcare or life sciences degree required • 15+ years of pharmacovigilance experience • 5+ years in a people-leadership role managing global PV teams • Experience with clinical and commercial lifecycle phases • Demonstrated experience managing PV Operations through multiple Health Authority inspections, including FDA, EMA, and MHRA • Experience spanning clinical-stage and commercial/post-marketing environments • Experience across multiple therapeutic areas is ideally preferred • Skilled in process gap assessments and process enhancements • Deep knowledge of pharmacovigilance regulations and guidelines

🏖️ Benefícios

• Annual performance incentive bonus • New hire equity • Ongoing performance-based equity • Medical insurance • Dental insurance • Vision insurance • 401(k) match • Flexible time off • Paid holidays

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