Senior Manager, Pharmacovigilance

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🕒 il y a 3 mois

🏄 California – Distant

🏄 California – Remote

💵 $150 000 - $180 000 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

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ORIC Pharmaceuticals Inc.

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2014

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

Biotechnology • Healthcare Insurance • Pharmaceuticals

ORIC Pharmaceuticals Inc. est une entreprise biopharmaceutique dédiée à cibler les mécanismes de résistance dans le traitement du cancer pour améliorer la vie des patients. L'entreprise a pour objectif de découvrir, développer et commercialiser des thérapies innovantes qui s'attaquent à la résistance au cancer, améliorant ainsi l'efficacité et la durée des traitements oncologiques actuels. Les recherches d'ORIC se concentrent sur diverses formes de résistance, notamment la résistance innée, acquise et par contournement, et mènent actuellement des essais cliniques pour ses thérapies phares, ORIC-114 et ORIC-944.

Description

• 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)

🎯 Exigences

• 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

🏖️ Avantages

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