Associate Director, Pharmacovigilance Operations

CG Oncology Inc• Remote, US,

41d•$180,000 - $205,000•Remote

About The Position

The Associate Director, Pharmacovigilance Operations leads day-to-day pharmacovigilance (PV) operations and vendor oversight for CG Oncology’s clinical and post-marketing safety activities. The role develops scalable, inspection-ready processes that support clinical development, BLA readiness, commercial launch preparation, regulatory compliance, and safety-data integrity. It 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. The role oversees global PV operations, vendors, case management, safety data, aggregate reporting, regulatory support, PV systems, commercial readiness, quality-system activities, and safety governance. It maintains PV documentation and controlled materials, supports audits and inspections, tracks operational performance and risks, and promotes accountability, collaboration, patient safety, inspection readiness, and data integrity. It may manage PV staff, contractors, consultants, or vendor resources and mentor junior team members.

Requirements

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline.
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.
Ability to support PV operations, compliance, vendor oversight, case management, safety data integrity, regulatory reporting, systems, quality processes, and governance as described in the role.

Nice To Haves

Advanced degree or clinical qualification.
Oncology experience; experience in NMIBC, bladder cancer, intravesical therapy, immuno-oncology, oncolytic viral therapy, or an adenoviral platform is desirable.
Experience supporting BLA/NDA submissions, launch readiness, audits, inspections, and outsourced PV operating models.

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 PV documentation and evidence.
Oversee PV vendors for case processing, safety databases, reporting gateways, literature surveillance, call center/intake, and aggregate reporting.
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 and mentor junior PV team members as needed.
Promote accountability, collaboration, patient safety, inspection readiness, and data integrity.