Pharmacovigilance Operations Manager

CG Oncology, Inc.; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Fully remote work environment

Unlimited flexible time off

401K with company match

Job summary

CG Oncology, Inc. is seeking a PV Operations Manager to lead global pharmacovigilance activities and ensure an inspection-ready system. You will oversee external safety vendors, monitor KPIs, and ensure compliance with SOPs and regulatory guidelines during audits and inspections.

The role requires a strong background in PV processes within a GxP environment, collaboration across functions, and a proactive approach to risk management. Remote work is supported for this position.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Minimum 5 years of pharmacovigilance operations experience.
• Direct clinical bedside patient care experience is highly preferred.

Responsibilities

• Oversee external safety vendors and CROs with KPI monitoring.
• Maintain an inspection-ready PV system and ensure SOP/regulatory compliance.
• Participate in audits and regulatory inspections with documentation.
• Collaborate with Clinical Operations, Regulatory Affairs, QA and other stakeholders.
• Lead process improvements and document PV activities.

Skills

PV operations

Vendor management

Regulatory knowledge

Leadership

Remote work

Education

Bachelor's in life sciences

Advanced degree preferred

Job description

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.