Associate Director, Pharmacovigilance Operations

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
  • Care for 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
  • Implement, validate, maintain, and enhance 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 authoring and maintaining PV SOPs, work instructions, forms, templates, training materials, and controlled documents.
  • Support deviations, investigations, CAPAs, change controls, audits, inspections, and mock inspection activities.
  • Cook up SRMT or safety governance agendas, minutes, signal trackers, action items, and decision documentation.

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.