[Remote] Pharmacovigilance Operations Manager

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