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Mark Banahan, EU-QPPV, Safety Project Manager, Product Specialist, Lifecycle Safety

IQVIA

Mark Banahan, EU-QPPV and Safety Project Manager within  Pharmacovigilance, graduated from University College Dublin (UCD) with an Honours degree in Neuroscience and Physiology and with an MSc in Medical Science. During his time at UCD he had several papers published on his work on Muscle Atrophy and Hypoxic Lung Disease. He joined IQVIA in September 2012 as a Drug Safety Associate. A year after joining IQVIA, he started a new position of Customer Delivery Manager where he was responsible for the management and service delivery excellence of assigned global clinical trial and Post Marketing safety projects, acting as the primary point of contact within Global Safety and Data Monitoring for internal and external customers. After gaining experience in all aspects of clinical trial and post marketing, in October 2015, he began a new role as Deputy QPPV supporting the EU-QPPV with the management, oversight and maintenance of the PV system while acting as back-up for the legal responsibilities of an EU QPPV, ensuring full compliance with EU pharmacovigilance standards. Since April 2016, he has acted as EU QPPV assuming the full responsibility of oversight of the PV system, acting as a single pharmacovigilance contact point for the competent authorities in Member States and the EMA on a 24-hour basis and also as a contact point for pharmacovigilance inspections.

 


Abstract

Challenges Faced in Working With Multiple Clients – a Service Provider’s Perspective

How to manage oversight of KPIs, Status reporting, Quality indicators, role technology and innovation

This presentation will cover how a service provider manages oversight of a Quality System of multiple clients through management of quality indicators such as Key Performance Indicators (KPIs) and status reporting. It will show how through a simple and streamlined governance structure we are able to provide joint oversight to the partnership between client and service provider to ensures high quality work is delivered within an open and transparent collaborative environment. We discuss how through development of individualised Quality Management Plans we set out a clear guidance of oversight between parties. We explore how applying our suite of standard KPIs for programme management and work with clients to define critical benchmarks for delivery to ensure quality and compliance to the client’s standards. Also discussed is the tips on managing service provider partnership and how outsourcing to a service provider can improve the PV system.

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