Purpose

The Director, OneHUB Product Safety Surveillance OUS provides leadership and oversight for the teams responsible for adverse event (AE) and product quality complaint (PQC) intake across markets outside the United States. This spans both in-house teams and third-party vendor partners delivering AE intake and OUS quality complaint intake across pharma/combination products and medical devices. The role manages operational delivery and vendor performance, ensures timely and accurate intake of safety and quality information across OUS markets and languages, and maintains compliance with applicable regional pharmacovigilance and quality regulations, GxP documentation standards, and AbbVie policies — operating within process standards and SOPs owned by the relevant business functions.

Responsibilities

• Lead operations for OUS adverse event (AE) and product quality complaint (PQC) intake, covering both in-house teams and third-party vendors across OUS markets, time zones, and languages.
• Oversee OUS quality complaint intake end-to-end across product types, including multilingual complaint intake and classification, complaint documentation, and coordination of sample-return logistics where applicable.
• Ensure AE and PQC cases are captured, documented, and routed accurately and on time, in line with regional regulatory reporting requirements.
• Manage vendor performance against defined SLAs and quality metrics, monitor non-technical service quality (including call quality and response standards), and keep internal business partners informed of outcomes and issues.
• Own workload forecasting and staffing planning across OUS markets, ensuring stays aligned with intake volumes and budget.
• Ensure teams follow applicable pharmacovigilance and quality procedures, GxP documentation standards, and local privacy requirements, operating within SOPs and process standards owned by the relevant business functions.
• Lead audit readiness and support internal and external audits and health authority inspections; own execution of non-technical operational corrective actions (CAPAs) and ensure findings are remediated on time.
• Serve as the operational point of contact for Global Safety and Post-Market Quality Assurance, translating regulatory and policy updates into operational adjustments to intake workflows, in coordination with the relevant business functions.
• Drive continuous improvement across OUS AE and PQC intake processes, focused on non-technical error reduction, documentation quality, and workflow efficiency.
• Identify, escalate, and mitigate operational risks that could affect patient safety or regulatory compliance.