Does Your Pharmacovigilance Project look Like a Subway Map?

  • October 25, 2018
  • Andrew

Editor’s note: This guest post is the seventh in a series from Larry Taber, BP3’s Digital Strategy Officer for Life Sciences and Pharma. Larry has over 32 years of deep pharmaceutical and biotech expertise ranging from discovery research to business development. He has over 17 years of leadership of international teams successfully partnering with over 100 companies. Larry is a proven business process problem-solving professional and trainer. He has completed Master Black Belt, Black Belt, and Malcolm Baldrige National Quality Award /Performance Excellence Examiner certifications. He is passionate about the incredible advances in medical science and the enablement that is being made possible for patients through digital technologies. He holds a M.S. in Medical Biochemistry from Indiana University Medical School and a B.S. in Chemistry (Magna Cum Laude) from Purdue University.]


Some years ago I attended Six Sigma conferences on a regular basis.  Based on my qualitative analysis and my human tendency to forget things that are unpleasant, I still can recall that at least 1 out of every 5 projects was somehow related to pharmacovigilance (PV).


Now, that could be good or bad.


Good, since patient safety was a high enough priority to justify the time and energy of skilled black belts exercising their disciplined DMAIC problem solving methods, over and over again.


Or, bad because the black belts were fixing lousy underlying process designs or they were tampering.  Doing what I like to call, “fixing the pain of the week”.   Imagine their frustration to learn that one part of the process was being “fixed” at the same time they were “fixing” their part, with each other knowing.  It happened.  Too often.


I suspect there was Good and Bad to all of it.


After all, PV is one of the most critical, core business processes for the pharmaceutical industry, so it is the right priority.


But, the belts could rarely define the basis for the current design or the fixes done previously.

And, they would often lament that they could not identify end-to-end process owner.


Core processes require formal business process management with a senior level individual accountable for the overall process design and performance, end-to-end.  They must keep the various users and stakeholders corralled to that the process activity swim lanes are clear and that they do not devolve or evolve into a convoluted mess . Digital tools for BPM (like PEGA, IBM Blueworks, etc.) are ideal for this purpose because they can document and make visibly accessible both the process, it’s design history, and tracking of digital transactions.


Because PV is a complex, multi-disciplinary process that is data intensive, it is also ideal for digital operations innovations.


Once the business process management fundamentals and BPM are in place, you can get off the cycle of Black Belts and IT wizards running you around in circle like an endless subway ride.


At BP3 we are recognized experts executing digital operations innovations every day and we do within the framework of proper business process management principles and tools.


Let us know if we can help you strengthen your PV, end-to-end. Email for more information.

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