key: cord-0787934-ny9ot46i
authors: Beninger, Paul
title: Influence of COVID-19 on the Pharmacovigilance Workforce of the Future
date: 2021-01-14
journal: Clin Ther
DOI: 10.1016/j.clinthera.2020.12.019
sha: 374747ac24413678d67eb27997e8a9f24ba3518a
doc_id: 787934
cord_uid: ny9ot46i

nan

"In the middle of difficulty lies opportunity." -Albert Einstein Amid 2020's trifecta of pathos -societal and political instability, economic disruption, and the pandemic death and disability that have followed the novel coronavirus -there have been unexpected opportunities recognized by innovators, 1 researchers 2 and especially healthcare leaders, 3 who have found themselves in the depth of caring for patients with COVID-19. Pharmacovigilance (PV), too, may well be the beneficiary of unexpected opportunities in these times. Over the past one-to-two decades, PV has taken shape as it has settled into three core disciplines -case management, signal management and benefit- The knowledge bases and skill sets that are needed to support PV's activities at these intersections are identified in the accompanying Table. At the top level, these fall into 2 basic types of knowledge bases and skill sets: 1) content-focused, which are generally performed by subject matter experts, and 2) process-focused, which are generally performed by operational experts. At the next level, developments in knowledge and skills have occurred in two parallel and mutually reinforcing components: 1) a quantitative component, with greater emphasis on statistically based approaches, and 2) a technological component, with increased emphasis on software platforms and artificial intelligence.

Beninger & Ibara have previously discussed the potential contributions of the latter. 5 Large-scale change, historically driven by innovative new technologies and regulatory pressures, has generally occurred incrementally. But the deeply felt effects marked by COVID-19 are forcing change at a jarring, quantum level. This may open the way for the application of behavioral economics and other soft-skill approaches that may have more direct impact on improving patient outcomes and reducing patient harms. This may be the "…middle of difficulty" in which lies the next opportunity. 

In addition to receiving a salary as a faculty member in the department of Public Health & Community Medicine at a private medical school, the author has received compensation as a topics editor for a medical journal since 2016, as a subject matter expert for AAAS in 2019, and as a training consultant for a pharmaceutical company in 2020.

J o u r n a l P r e -p r o o f

Unexpected opportunities for innovators in the post COVID world

Friedman lab finds unexpected opportunities in COVID adjusted research activities

The unexpected side effect of COVID-19: Collaboration

S population growth slowing to a crawl

Pharmacovigilance and Biomedical Informatics: A Model of Future Development

Global and country level time series analyses of the effect of the COVID-19 pandemic on spontaneous reporting

Time Series Disturbance Detection for Hypothesis-Free Signal Detection in Longitudinal Observational Databases

Finding the missing link for big biomedical data

J o u r n a l P r e -p r o o f Table. Scope of pharmacovigilance domain-facing activities in the context of knowledge bases and skill sets needed to support these activities.