Pharmacovigilance Operations Manager

CG Oncology

2d•Remote

About The Position

CG Oncology is advancing innovative oncology therapies and preparing for a critical transition from late-stage clinical development to commercialization. We’re seeking a Pharmacovigilance Operations Manager to help build, scale, and operate a world-class PV organization that is inspection-ready, compliant, and built for growth. This is not a maintenance role. It’s an opportunity to own PV operations, shape vendor strategy, and directly influence patient safety and regulatory outcomes as products move toward approval.

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

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