Note: The job is a remote job and is open to candidates in USA. CG Oncology is hiring an Associate Director, Pharmacovigilance Operations to lead day-to-day pharmacovigilance operations and vendor oversight for clinical and post-marketing safety activities. The role develops scalable, inspection-ready processes and works cross-functionally to support clinical development, regulatory compliance, BLA readiness, and commercial launch preparation.
Responsibilities
- 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
- 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
- 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
- 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
- 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
- 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
Skills
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline required
- 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
- Advanced degree or clinical qualification preferred
- 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
Benefits
- Annual performance bonuses
- Equity
- Special recognition
- Fully remote work environment
- Unlimited flexible time off
- 14 holidays in 2026
- 401(k) with 100% company Safe Harbor match up to 4% of base salary
- Medical, dental, and vision coverage (PPO and HDHP; Cigna/Principal)
- HSA with annual company contribution, FSA, and FSA-DC
- Company-paid LTD coverage and voluntary plans
- Company-paid life insurance equal to 2x base salary and voluntary plans
- Voluntary legal and pet benefits, plus more
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