Pharmacovigilance Operations Manager
CG Oncology
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $119,000 - $140,000 per year
About the role
- Own day-to-day operational oversight of pharmacovigilance activities across global clinical trials
- Ensure regulatory compliance, inspection readiness, and data quality in a GxP environment
- Build and manage PV vendor oversight models that scale into commercial operations
- Play a key role in the clinical-to-commercial transition, supporting post-marketing PV readiness
- Partner closely with Clinical Operations, Clinical Development, Regulatory, Medical, Biostatistics, and Quality
Requirements
- Have 5+ years of experience in pharmacovigilance operations within clinical development
- Understand global PV regulations (FDA, EMA, ICH) and how they work in practice
- Have managed external PV vendors and held them accountable to performance and quality standards
- Are comfortable operating with autonomy in a fast-moving, high-growth biotech environment
- Enjoy building systems and processes, not just running them
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
pharmacovigilanceregulatory compliancedata qualityGxPclinical developmentvendor managementperformance standardsquality standardssystem buildingprocess building
Soft Skills
operational oversightautonomycollaborationcommunicationleadershiporganizational skillsadaptabilityproblem-solvingstrategic thinkingattention to detail