Reporting to our Associate Director, Global Safety Operations you will support the establishment and maintenance of effective compliance and oversight for external providers of pharmacovigilance (PV) services for AbbVie affiliates. In addition, you ensure all activities meet global regulatory standards, AbbVie policies, and local PV regulations. You will oversee outsourced services and vendors, including adverse event management, reporting, and related processes for all marketed products.

Key Responsibilities:

• Establish and monitor standards for outsourced PV activities; investigate and lead follow-ups on process discrepancies
• Lead monitoring of supplier performance, analyze SLAs and metrics; prepare routine/ad hoc reports and investigate trends, escalating issues as needed
• Present quality control and trend analysis to senior cross-functional stakeholders
• Support and implement AbbVie quality management systems for external PV suppliers, ensuring consistent delivery of high-quality outputs
• Collaborate with suppliers and internal teams to integrate vendor quality management processes
• Develop and deliver compliance training, including train-the-trainer and refresher sessions, as well as internal and external education
• Lead investigation of CAPAs and coordinate issue resolution and remediation actions across stakeholders
• Perform, document, and improve quality control on outsourced processes
• Proactively drive improvements in compliance and QC approaches adapting to regulatory and business changes
• Play an active role within the Affiliate PV Operations team to drive compliance and business excellence in all outsourced affiliate PV activities