Note: The job is a remote job and is open to candidates in USA. CG Oncology, Inc. is hiring a Pharmacovigilance Operations Manager to oversee clinical trial safety operations, external safety vendors, and the company’s global pharmacovigilance activities. The role maintains an inspection-ready PV system and supports compliant, scalable safety operations through cross-functional collaboration, process improvement, documentation, and training.
Responsibilities
- Manage relationships with external safety vendors, including contract research organizations (CROs) and case processing providers
- Monitor vendor performance through KPIs and quality metrics; implement corrective actions as needed
- Support and maintain PV processes to ensure an inspection-ready system at all times
- Oversee compliance with SOPs, regulatory guidelines, and company policies
- Participate in audits and regulatory inspections, providing documentation and subject matter expertise
- Support the continued growth and maturation of the PV infrastructure to ensure scalable, compliant, inspection-ready operations that protect patient safety and maintain the integrity, accuracy, and security of safety data
- Work closely with Clinical Operations, Regulatory Affairs, Quality Assurance, and other stakeholders to ensure seamless safety data flow
- Contribute to safety governance meetings and provide operational input on risk management plans and safety strategies
- Identify opportunities for process optimization and implement best practices in PV operations
- Maintain accurate documentation of PV activities, including safety management plans and vendor oversight plans
- Provide training and guidance to internal teams and vendors on PV processes and compliance requirement
Skills
- Bachelor's degree in life sciences or related field
- Minimum 5 years of experience in pharmacovigilance operations within clinical development
- Minimum of 4 years of recent oncology experience
- NMIBC or GU Cancer experience
- Minimum of 3 years of people leadership and/or experience leading pharmacovigilance operations, cross-functional initiatives, or vendor management
- Strong knowledge of global PV regulations (ICH, FDA, EMA, etc.)
- Experience managing external vendors and ensuring compliance with contractual obligations
- Excellent organizational, communication, and problem-solving skills
- Advanced degree
- Direct clinical bedside patient care experience (e.g., RN, NP, PA, or other licensed healthcare professional)
- NMIBC or GU Cancer experience
Benefits
- Annual performance/merit reviews
- Annual performance bonuses
- Equity
- Special recognition
- Fully remote work environment
- Unlimited flexible time off
- 14 observed holidays in 2026
- 401(k) with 100% company Safe Harbor match up to 4% of base salary
- Medical, dental, and vision coverage (PPO and HDHP) through Cigna/Principal
- HSA with annual company contribution, FSA, and FSA-DC
- Company-paid LTD coverage and voluntary plans
- Company-paid life insurance at 2x base salary, plus voluntary plans
- Voluntary legal and pet benefits, plus more
- Well-Being Benefits eligibility begins the 1st of the month after hire
Company Overview
Company H1B Sponsorship