Remote Associate Director, Pharmacovigilance Ops

CG Oncology, Inc.; United States; On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Fully remote work environment

401K with company match

Health Spending Accounts

Life Insurance

Illness & Disability protection

Job summary

CG Oncology is seeking an Associate Director, Pharmacovigilance Operations to lead day-to-day PV operations and vendor oversight for clinical and post-marketing safety activities. This role drives scalable, inspection-ready processes supporting clinical development, regulatory readiness, and data integrity.

Reporting to the Senior Director, PV, you will partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, IT, and external PV partners to ensure safety data

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline required; advanced degree preferred.
• Approximately 10+ years of PV, drug safety, or clinical safety experience in biotech, pharma, CRO, or vendor environments.
• At least 5 years of increasing responsibility in PV Operations leadership and vendor oversight.

Responsibilities

• Lead day-to-day PV operations across clinical and post-marketing activities.
• Oversee PV vendors, including case processing, literature surveillance, and aggregate reporting.
• Maintain inspection-ready PV documentation and evidence.
• Coordinate PV systems, dashboards, and data integrity initiatives.

Skills

PV Operations leadership

Vendor oversight

Regulatory compliance

Clinical safety coordination

Education

Bachelor's degree in Life Sciences or related

Advanced degree or clinical qualification preferred

Tools

Safety databases

Reporting gateways

QA / PV systems

Job description

CG Oncology is seeking an Associate Director, Pharmacovigilance Operations to lead day-to-day PV operations and vendor oversight for clinical and post-marketing safety activities. This role drives scalable, inspection-ready processes supporting clinical development, regulatory readiness, and data integrity.

Reporting to the Senior Director, PV, you will partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, IT, and external PV partners to ensure safety data