Pharmacovigilance Operations Manager
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Job Description
Pharmacovigilance Operations Manager at CG Oncology focusing on operational oversight and regulatory compliance. Driving pharmacovigilance activities and supporting clinical-to-commercial transitions.
Responsibilities:
- 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:
- HIGHLY COMPETITIVE SALARIES
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS –In 2025 we will observe 14 holidays
- RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
- HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
- HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
- ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
- LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
- ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
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