V Is For Vigilance

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When my youngest son asked me what I did for my job, I gave the standard response that I helped to protect the safety of patients that receive medicines. But then he asked me what I really did, and I was stumped. I could have listed all the regulations and guidance, activities and outputs, but I quickly realized that I would never be able to do it in a way that would make sense to a fifth grader. That got me thinking about the core of what I do in the most basic sense.

Too often, we are focused on safety case processing workflow, given the regulatory focus on late cases. Especially when dealing with a product that is developed and marketed globally with many development and commercialization business partners. All in the context of a PV quality management system that encompasses everything from SOPs, training, CAPAs, vendor and system management. This does not even include the scientific and medical evaluation of individual case and aggregate safety reports. It is all too easy to lose sight of the one thing that is core, and it is not something we do. So what is at the core of pharmacovigilance? Quite simple, really - Vigilance!

Dictionary.com defines vigilance as the state or quality of being vigilant; watchfulness. Which is fine, but not that helpful. As with most things, the most important question is usually why. Why would anyone be vigilant? Is it because someone instructed them to be vigilant? Or is it in their job description? Or something else? Fundamentally, it is because we care. We care about the patient, about doing the right thing, about doing things right.

A reminder for all the pharmacovigilance professionals out there - let's not just focus on the what, how and when, but let's remember the why of what we do. For everyone else for which the above rings true, pharmacovigilance may be right fit for you.