Associate Director, Pharmacovigilance Operations

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

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

The Associate Director, Pharmacovigilance Operations will lead day-to-day PV operations and vendor oversight for CG Oncology's clinical and post-marketing safety activities. This role is responsible for scalable, inspection-ready processes that support clinical development, BLA readiness, commercial launch preparation, regulatory compliance, and the integrity and accuracy of safety data.

The position serves as an operational deputy to the Senior Director, Pharmacovigilance and works closely with Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, Alliance Management, IT, and external PV partners.

Essential Functions

PV Operations and Compliance

• Lead execution and oversight of global PV operations across clinical trial and post-marketing activities.
• Ensure processes align with applicable FDA, EMA, ICH, GCP, and GVP expectations.
• Drive operational improvements, risk mitigation, issue escalation, and inspection readiness.
• Maintain complete, traceable, and inspection-ready PV documentation and evidence.

Vendor Oversight and Governance

• Oversee PV vendors, including case processing, safety database, reporting gateway, literature surveillance, call center/intake, and aggregate reporting providers.
• Manage vendor governance meetings, KPIs, SLAs, action items, quality trends, issue escalation, and CAPA follow-up.
• Support vendor qualification, onboarding, annual assessments, audits, quality agreements, SDEAs, and offboarding.

Case Management and Safety Data Integrity

• Oversee ICSR intake, triage, data entry, MedDRA coding, narratives, medical review coordination, quality review, submissions, and follow-up.
• Monitor expedited reporting compliance and case quality metrics.
• Ensure reconciliation across clinical operations, partners, medical information, product complaints, and vendors.
• Support high-quality safety data outputs for aggregate reporting, signal detection, regulatory requests, and BLA readiness.

Aggregate Reporting and Regulatory Support

• Coordinate PV operations inputs for DSURs, PADERs, PSURs/PBRERs, annual reports, BLA/NDA safety modules, and ad hoc regulatory requests.
• Maintain reporting calendars, data cut timelines, review cycles, and evidence of completion.
• Track safety-related regulatory commitments and operational deliverables.

PV Systems, Launch Readiness, and Post-Marketing Infrastructure

• Support implementation, validation, maintenance, and enhancement of safety databases, reporting gateways, dashboards, and PV tools.
• Partner with IT, Quality, and vendors on system requirements, access, change control, UAT, migration, and issue resolution.
• Advance commercial PV readiness, including PSMF support, intake pathways, literature surveillance, product complaint and medical information interfaces, and partner data exchange processes.

Quality System and Safety Governance Support

• Author and maintain PV SOPs, work instructions, forms, templates, training materials, and controlled documents.
• Support deviations, investigations, CAPAs, change controls, audits, inspections, and mock inspection activities.
• Coordinate SRMT or safety governance agendas, minutes, signal trackers, action items, and decision documentation.
• Serve as a primary PV Operations liaison with internal functions and external partners.
• Present operational metrics, risks, vendor performance, and readiness updates to PV leadership and governance forums.
• May manage PV staff, contractors, consultants, or vendor resources; mentor junior PV team members as needed.
• Promote accountability, collaboration, patient safety, inspection readiness, and data integrity

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline required; advanced degree or clinical qualification preferred.
• Approximately 10 or more years of PV, drug safety, clinical safety, or related experience in biotechnology, pharmaceutical, CRO, or vendor environments.
• At least 5 years of increasing responsibility in PV Operations leadership, vendor oversight, safety compliance, or PV quality activities.
• Experience with both clinical trial safety and post-marketing PV operations required.
• Oncology experience strongly preferred; NMIBC, bladder cancer, intravesical therapy, immuno-oncology, oncolytic viral therapy, or adenoviral platform experience desirable.
• Experience supporting BLA/NDA submissions, launch readiness, audits, inspections, and outsourced PV operating models strongly preferred.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2026 we will observe 14 holidays
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 2x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

CG Oncology is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.