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European Biopharmaceutical Review

Strategic Advantage

Pharmacovigilance (PV) is beginning to touch more aspects of life sciences organisations in the form of additional functions as well as international operations, including affiliates. Overcoming silos and establishing closer collaboration between PV and quality operations is a growing priority and, as circumstances evolve, responsibility for the monitoring of safety and associated systems will have to be shared by an increasingly diverse range of stakeholders.

Quality Rules


One thing the life sciences industry cannot escape is a heightened emphasis on quality as inspections increase. Although this presents certain obstacles, it also prompts companies to put better systems and processes in place Ė senior management now understands the importance of PV and are beginning to allocate more resources to it.

The conceivable downside is that too much attention on compliance could detract from the real motivation underlying all of this which is, of course, to improve patient safety and public confidence. Two ways of keeping things in clear focus are to get teams working together more readily and to take shared responsibility for making improvements.

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Cheryl Key, MBBS, MFPM, is Head of Practice PV Platform Services and Principal Medic at ProductLife Group, with final responsibility for all projects, programmes and engagements in the platform, as well as for day-to-day management of the platform team. She has a medical degree from Charing Cross and Westminster Medical School, UK, a diploma in pharmaceutical medicine, membership of the Royal College of General Practitioners and membership of the Faculty of Pharmaceutical Medicine. Cheryl is also on the Specialist Register at the General Medical Council for Pharmaceutical Medicine and a member of the board of the Faculty of Pharmaceutical Medicine.
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Cheryl Key
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