Overcoming Resistance In Cancer
Senior Manager, Pharmacovigilance
Location
California
Posted
3 days ago
Salary
$150K - $180K / year
Seniority
Senior
Job Description
Senior Manager, Pharmacovigilance
ORIC Pharmaceuticals Inc.
• 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
Job 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
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