Senior Manager, Pharmacovigilance

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🕒 Fevereiro 27

🏄 California – Remoto

🏄 California – Remote

💵 $150.000 - $180.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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ORIC Pharmaceuticals Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2014

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

Biotechnology • Healthcare Insurance • Pharmaceuticals

A ORIC Pharmaceuticals Inc. é uma empresa biofarmacêutica dedicada a direcionar mecanismos de resistência no tratamento do câncer para melhorar a vida dos pacientes. A empresa tem como objetivo descobrir, desenvolver e comercializar terapias inovadoras que abordem a resistência ao câncer, aumentando a eficácia e a duração dos tratamentos oncológicos atuais. A pesquisa da ORIC foca em várias formas de resistência, incluindo resistência inata, adquirida e por desvio, e está ativamente conduzindo ensaios clínicos para suas terapias líderes, ORIC-114 e ORIC-944.

Descrição

• Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products • Oversee intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelines • Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/ECs, clinical investigators, and business partners • Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs) • Develop, maintain and execute Safety Management Plans for clinical studies • Contribute to safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable) • Review clinical trial safety data and assist with data cleaning for ongoing studies • Participate in periodic safety reviews, signal detection and risk evaluation activities • Maintain Reference Safety Information for ORIC products and co-administered IMPs • Support launch readiness activities including development of post-marketing pharmacovigilance processes, development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable)

🎯 Requisitos

• Bachelor’s degree in life sciences, pharmacy, nursing, or related discipline with demonstrated knowledge of medical terminology • 12 years’ pharmacovigilance experience with Bachelor's degree -or- 8 years’ experience and Master's degree -or- 5 years’ experience and PhD-including clinical trial and/or post-marketing experience • Experience with small-molecule oncology products • Working knowledge of global pharmacovigilance regulations, including FDA, EMA, Health Canada, and Asian Health Authorities (e.g., Japan PMDA, South Korea MFDS) • Experience using validated safety databases (e.g., Argus, ARISg) and clinical trial databases

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities