Remote Global PV Operations Leader

Evolving Solution Services; United States; Remote; USD 123,000 - 145,000; Full time

Benefits offered by this job

Fully remote work environment

401K with company match

Well-being benefits

Job summary

CG Oncology, Inc. is seeking a Pharmacovigilance Operations Manager to lead global PV activities, vendor oversight, and inspection readiness in a fully remote US-based role.

You will collaborate with Clinical Operations, Regulatory Affairs, and Quality Assurance to ensure safety data integrity, regulatory compliance, and scalable PV processes across trials and post-marketing activities. The ideal candidate brings 5+ years in PV operations within clinical development.

Qualifications

• 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.

Responsibilities

• Oversee clinical trial safety operations and PV activities.
• Manage relationships with external safety vendors (CROs and case-processing providers).
• Ensure inspection-ready PV system and compliance with SOPs and regulatory guidelines.
• Support audits and regulatory inspections with documentation and SME input.
• Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, and other stakeholders for safe data flow.
• Identify opportunities for PV process improvements and document PV activities.

Skills

PV regulations

Vendor management

Regulatory audits

Communication

Problem solving

Education

Bachelor’s degree in life sciences or related field

Job description

CG Oncology, Inc. is seeking a Pharmacovigilance Operations Manager to lead global PV activities, vendor oversight, and inspection readiness in a fully remote US-based role.

You will collaborate with Clinical Operations, Regulatory Affairs, and Quality Assurance to ensure safety data integrity, regulatory compliance, and scalable PV processes across trials and post-marketing activities. The ideal candidate brings 5+ years in PV operations within clinical development.