Senior Director, Risk Management

🕒 Março 5

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Vera Therapeutics, Inc.

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201 - 500 funcionários

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

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

• Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures to ensure patient safety is at the forefront of DSPV. • Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide. • Provide recommendations and guidance through subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment documentation. • Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes. • Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. • Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations. • Remain up to date and well informed on all Regulatory intelligence as it relates to risk management and relay this to the Project team and the PV medical safety science team. • Aide in the development and review risk minimization documents such as Developmental RMPs, RMPs, risk minimization measures and Risk Evaluation and Mitigation Strategy (REMS).

🎯 Requisitos

• PhD/Pharmacist/ PharmD/DO/MD with 12+ years of experience. • Minimum 5-10 years in PV/safety OR clinical development preferred. • Minimum 5-10 years of pharmaceutical industry/drug development experience. • Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures, and/or REMS programs preferred. • Strong track record of scientific and analytical thinking. • Experience presenting at meetings is desirable. • Good Critical thinking skills. Ability to use good analytical/judgment skills to understand, analyze, and communicate. • Project Management Skills with ability to manage both time and priority constraints and to manage multiple priorities simultaneously. • Attention to detail, computer literacy, knowledge of safety databases. • Good working knowledge of all the functions within PV from PV operations onto medical safety science and all processes in between.

🏖️ Benefícios

• health insurance • 401(k) matching • Flexible working hours • Paid time off