Remote Pharmacovigilance Operations Leader | Equity & Growth

CG Oncology; United States; On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Fully remote work environment

Annual performance bonuses

Equity

401K with company match

Comprehensive health plans

Job summary

CG Oncology is seeking a PV Operations Manager to lead global pharmacovigilance activities, ensuring compliant safety operations and an inspection-ready system. You will manage external safety vendors and drive process improvements while collaborating with Clinical Operations, Regulatory Affairs, and QA to maintain data integrity and safety governance.

The role requires 5+ years in PV operations, strong regulatory knowledge, and the ability to travel quarterly.

Qualifications

• Experience in pharmacovigilance operations within clinical development.
• Strong knowledge of global PV regulations (ICH, FDA, EMA).
• Experience managing external vendors and ensuring contractual compliance.
• Ability to work independently in a remote environment and travel quarterly to corporate offices.

Responsibilities

• Oversee clinical trial safety operations and PV activities.
• Manage external safety vendors including CROs and case processing providers.
• Maintain inspection-ready PV system and ensure SOP/regulatory compliance.
• Collaborate with Clinical Operations, Regulatory Affairs, QA and stakeholders for safe data flow.
• Identify and implement PV process improvements and maintain documentation.
• Provide PV process training and oversight to internal teams and vendors.

Skills

Vendor management

Regulatory knowledge

Communication skills

Problem-solving

Independent work in remote environment

Education

Bachelor’s degree in life sciences or related field

Job description

CG Oncology is seeking a PV Operations Manager to lead global pharmacovigilance activities, ensuring compliant safety operations and an inspection-ready system. You will manage external safety vendors and drive process improvements while collaborating with Clinical Operations, Regulatory Affairs, and QA to maintain data integrity and safety governance.

The role requires 5+ years in PV operations, strong regulatory knowledge, and the ability to travel quarterly.