Senior Manager, Pharmacovigilance

🕒 vor 23 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $150.000 - $180.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

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ORIC Pharmaceuticals Inc.

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2014

🏥 Gesundheitswesen

💼 Beratung

🍽️ Lebensmittel & Getränke

Healthcare • Consulting • Food & Beverage

ORIC Pharmaceuticals Inc. ist ein biopharmazeutisches Unternehmen, das sich der Bekämpfung von Resistenzmechanismen in der Krebstherapie widmet, um das Leben der Patienten zu verbessern. Das Unternehmen strebt danach, innovative Therapien zu entdecken, zu entwickeln und zu vermarkten, die Krebsresistenzen adressieren und die Wirksamkeit und Dauer aktueller Onkologiebehandlungen verbessern. Die Forschung von ORIC konzentriert sich auf verschiedene Formen von Resistenzen, einschließlich angeborener, erworbener und Umgehungsresistenz, und führt aktiv klinische Studien für seine führenden Therapien ORIC-114 und ORIC-944 durch.

Beschreibung

• 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) • Assist with preparation for regulatory inspections and audits • Participate in internal Safety Management Teams and governance meetings • Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams • Support safety training for internal stakeholders and investigators • Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained

🎯 Anforderungen

• 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

🏖️ Vorteile

• Health insurance • Retirement plans • Flexible work arrangements • Paid time off • Professional development opportunities