Senior Manager, Pharmacovigilance

🔥 5 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $150k - $180k / year

⏰ Full Time

🟠 Senior

👔 Manager

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ORIC Pharmaceuticals Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

ORIC Pharmaceuticals Inc. is a biopharmaceutical company dedicated to targeting resistance mechanisms in cancer treatment to improve patients' lives. The company aims to discover, develop, and commercialize innovative therapies that address cancer resistance, enhancing the effectiveness and duration of current oncology treatments. ORIC's research focuses on various forms of resistance, including innate, acquired, and bypass resistance, and is actively conducting clinical trials for its leading therapies, ORIC-114 and 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) • 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

🎯 Requirements

• 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

🏖️ Benefits

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