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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, vision care, virology, women’s health , and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

Summary: 

Support the establishment and maintenance of effective compliance & oversight of external providers of pharmacovigilance services for AbbVie affiliates. At a minimum this system must ensure compliance with global regulatory requirements, AbbVie standards and local PV regulations. The scope extends to all externalized services and providers overseen by PPS on behalf of AbbVie affiliates, including adverse event management, reporting, and related operational activities, and spans all marketed products.

Responsibilities :

• Manages standards and oversees the monitoring of outsourced processes, investigates and leads the follow-up of discrepancies.
• Manages the monitoring of supplier performance via SLAs and other metrics, prepares routine and ad hoc reports, leads the investigation of trends, and escalates issues as appropriate.
• Supports presentations of quality control results and trend analysis to senior, cross-functional AbbVie stakeholders.
• Support the establishment of AbbVie quality management processes for external suppliers of affiliate pharmacovigilance services that meet applicable PPS, RDQA, and affiliate standards and ensure reproducible, controlled, and timely delivery of high quality outputs.
• Collaborate with suppliers and internal partners to implement vendor quality management processes which integrate with supplier and AbbVie processes wherever possible. Support the use of risk-proportionate approaches for in-line and retrospective evaluations.
• Supports development of materials and delivers training sessions (through multiple modalities) in conjunction with supplier, including train-the-trainer, special-topics, refresher, and internal AbbVie trainings as needed.
• Manages issue investigation (eg CAPAs), coordinating between AbbVie and supplier systems. Supports the communication and collaborates across internal and partner stakeholders for prioritization of issues, as well as timely, effective, and permanent remediation actions.
• Performs quality control (QC) of all outsourced processes reliable documents results; proactively identifies areas of process and technical improvement and supports the implementation of changes.
• Proactively suggests changes in QC approaches to account for external and internal process, regulatory and business change.
• Responsible as a member of the Affiliate PV Operations team for driving compliance and business excellence for all of outsourced affiliate PV activities.