Remote Pharmacovigilance Operations Leader

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

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.