Global Pharmacovigilance Operations Leader - Remote

CG Oncology, Inc.; United States; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Fully remote work environment

Well-Being benefits

Job summary

CG Oncology, Inc. is seeking a PV Operations Manager to ensure operational excellence across global pharmacovigilance activities.

The role includes oversight of external safety vendors, maintaining an inspection-ready system, and ensuring ongoing compliance with regulatory guidelines. The successful candidate will lead PV processes, drive improvements, and collaborate with Clinical Operations, Regulatory Affairs and QA to safeguard patient safety while enabling scalable, compliant PV

Qualifications

• Minimum 5 years of experience in pharmacovigilance operations within clinical development.
• Direct clinical bedside patient care experience (RN, NP, PA, or other licensed healthcare professional) is highly preferred.
• Minimum of 3 years of people leadership and/or experience leading pharmacovigilance operations, cross-functional initiatives, or vendor management.

Responsibilities

• Oversee PV operations and external safety vendor management.
• Maintain an inspection-ready PV system and ensure compliance with SOPs and regulatory guidelines.
• Support audits and regulatory inspections with documentation and SME input.
• Collaborate with Clinical Operations, Regulatory Affairs, QA and other stakeholders for seamless safety data flow.
• Identify opportunities for PV process optimization and documentation updates.
• Provide training and guidance on PV processes to teams and vendors.

Skills

PV operations

Vendor management

Regulatory compliance

Cross-functional collaboration

Leadership

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

CG Oncology, Inc. is seeking a PV Operations Manager to ensure operational excellence across global pharmacovigilance activities.

The role includes oversight of external safety vendors, maintaining an inspection-ready system, and ensuring ongoing compliance with regulatory guidelines. The successful candidate will lead PV processes, drive improvements, and collaborate with Clinical Operations, Regulatory Affairs and QA to safeguard patient safety while enabling scalable, compliant PV