Pharmacovigilance Operations Manager

About CG Oncology, Inc. Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world. Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world. Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you. About The Role The PV Operations Manager will play a critical role in ensuring the operational excellence of CG Oncology’s global pharmacovigilance (PV) activities. This position is responsible for oversight of clinical trial safety operations, management of external safety vendors, and maintaining an inspection-ready PV system at all times. The ideal candidate is detail-oriented, collaborative, and experienced in PV processes within a GxP-regulated environment. Essential Functions Clinical Trial & Post- Market PV Oversight: Vendor Management 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. PV System & Compliance 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. Collaboration & Cross-Functional Support 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. Process Improvement & Documentation 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. Training & Oversight Provide training and guidance to internal teams and vendors on PV processes and compliance requirement Qualifications Bachelor’s degree in life sciences or related field; advanced degree preferred Minimum 5 years of experience in pharmacovigilance operations within clinical development. Direct clinical bedside patient care experience (e.g., RN, NP, PA, or other licensed healthcare professional) is highly preferred. Minimum of 4 years of recent oncology experience, NMIBC or GU Cancer experience is highly preferred. 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. Ability to work independently in a remote environment and travel quarterly to corporate offices. Total Rewards HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/MERIT REVIEWS ANNUAL PERFORMANCE BONUSES EQUITY SPECIAL RECOGNITION Well-Being Benefits In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work. Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered. FULLY REMOTE WORK ENVIRONMENT REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off HOLIDAYS –In 2026 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 2 x base salary + Voluntary Plans ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More CG Oncology Is An Equal Opportunity Employer All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability. #J-18808-Ljbffr