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.
Education
- Bachelor’s degree in nursing or a scientific field preferred; advanced degree desirable.
Experience
- 8+ years of clinical development, pharmacovigilance, or directly related experience, including 4 or more years of direct management experience.
- Demonstrated experience operating across OUS / international markets, with cross-discipline exposure to clinical safety and/or product quality complaint reporting.
Functional & Regulatory Knowledge
- Extensive knowledge of clinical safety and/or product quality complaint reporting and intake processes.
- Strong understanding of the global and OUS operating environment from both operational and regulatory/GVP/GCP perspectives, including EU and other regional health authority frameworks.
- Fluency in standard business procedures (SOPs, global/regional regulations, ethics and compliance, outsourcing/vendor management, PV/PQC) and their application to the business.
Leadership & Competencies
- Proven organizational, project management, and leadership skills, with the ability to lead the OneHUB OUS Product Safety Surveillance team within a global matrix environment.
- Demonstrated ability to build effective working relationships across functions and geographies, applying industry best practices that drive process improvement across OUS markets.
Key Stakeholders
OneHUB leadership team; International Strategy & Safety Operations function leadership team; Post Market Quality Assurance function leadership team; Global Patient Safety / Pharmacovigilance organization (including the EU QPPV office); Regulatory Affairs and Commercial Quality functions; OUS affiliates and regional safety and quality leads; Outsourced third-party vendor partners
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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