Pharmacovigilance Operations Manager

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Full Time Remote, US

2 days ago Requisition

Salary Range: $ To $ Annually

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.

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.

Clinical Trial & Post
- Market PV Oversight:

• 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

• Bachelor’s degree in life sciences or related field; advanced degree preferred
• Minimum 5 years of experience in pharmacovigilance operations within clinical development.
• 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.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

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• ANNUAL PERFORMANCE…