Pharmacovigilance Operations Manager

CG Oncology Inc• Remote, US,

25d•$130,000 - $145,000•Remote

About The Position

The PV Operations Manager plays a critical role in ensuring operational excellence across CG Oncology’s global pharmacovigilance activities. The position oversees clinical-trial safety operations, manages external safety vendors, and supports an inspection-ready pharmacovigilance system in a GxP-regulated environment. The role works with internal and external stakeholders to maintain compliant, scalable operations that protect patient safety and preserve the integrity, accuracy, and security of safety data. Responsibilities include vendor oversight; maintaining PV processes and compliance with SOPs, regulatory guidelines, and company policies; supporting audits and regulatory inspections; collaborating across Clinical Operations, Regulatory Affairs, and Quality Assurance; contributing operational input to safety governance, risk management plans, and safety strategies; improving processes; maintaining PV documentation; and training internal teams and vendors. The role is fully remote and requires quarterly travel to corporate offices. CG Oncology offers competitive salaries, annual performance and merit reviews, performance bonuses, equity, recognition, and a range of well-being benefits.

Requirements

Bachelor’s degree in life sciences or a related field.
At least 5 years of pharmacovigilance operations experience within clinical development.
At least 4 years of recent oncology experience.
At least 3 years of people leadership and/or experience leading pharmacovigilance operations, cross-functional initiatives, or vendor management.
Strong knowledge of global PV regulations, including ICH, FDA, and EMA requirements.
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.
Ability to travel quarterly to corporate offices.

Nice To Haves

Advanced degree.
Direct clinical bedside patient-care experience, such as RN, NP, PA, or another licensed healthcare professional.
NMIBC or GU cancer experience.

Responsibilities

Manage relationships with external safety vendors, including CROs and case-processing providers.
Monitor vendor performance using KPIs and quality metrics, and implement corrective actions as needed.
Support and maintain PV processes to keep the system inspection-ready.
Oversee compliance with SOPs, regulatory guidelines, and company policies.
Participate in audits and regulatory inspections, providing documentation and subject-matter expertise.
Support the growth and maturation of PV infrastructure to enable scalable, compliant, inspection-ready operations and protect patient safety and safety-data integrity, accuracy, and security.
Collaborate 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 to optimize processes 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 requirements.