Remote PV Operations Associate Director

CG Oncology; United States; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Fully remote work

Unlimited time off (Rest and Recharge)

14 holidays (2026)

401K with company match up to 4%

Medical, Dental, Vision (PPO/HDHP)

HSA/FSA

Disability protection (LTD)

Life Insurance

Voluntary legal & pet benefits

Job summary

CG Oncology seeks an Associate Director, Pharmacovigilance Operations to lead day-to-day PV operations and vendor oversight across clinical and post-marketing safety activities. This role ensures scalable, inspection-ready processes supporting development, BLA readiness, and regulatory compliance.

The position reports to the Senior Director, Pharmacovigilance and collaborates with Clinical Development, Regulatory Affairs, Medical Affairs, QA, IT, and external PV partners to drive data integrity

Qualifications

• Extensive PV/drug safety experience with clinical and post-marketing activities.
• Experience leading PV operations and vendor oversight with regulatory focus.
• Experience supporting BLA/NDA submissions and launch readiness is preferred.

Responsibilities

• Lead global PV operations across clinical and post-marketing safety activities.
• Oversee case processing, safety data management, and documentation quality.
• Manage vendor governance, KPIs, SLAs, and CAPA follow-up.
• Coordinate safety outputs for regulatory submissions and DSUR/PSUR reports.
• Ensure inspection readiness and data integrity across partners and systems.

Skills

PV Operations leadership

Vendor oversight

Regulatory compliance

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline

Job description

CG Oncology seeks an Associate Director, Pharmacovigilance Operations to lead day-to-day PV operations and vendor oversight across clinical and post-marketing safety activities. This role ensures scalable, inspection-ready processes supporting development, BLA readiness, and regulatory compliance.

The position reports to the Senior Director, Pharmacovigilance and collaborates with Clinical Development, Regulatory Affairs, Medical Affairs, QA, IT, and external PV partners to drive data integrity