[Remote] Associate Director, Pharmacovigilance Operations

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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