ABSTRACT
Purpose: The COVID-19 pandemic poses an unprecedented threat to global business relationships and dynamics. The pharmacovigilance function of pharmaceutical companies is particularly susceptible to changing external pressures because of its highly structured compliance activities. We conducted an industry-wide survey to provide insights on the how the pharmacovigilance function responded to the challenges posed by the pandemic. We compared smaller companies and larger companies regarding impact on portfolios and on operational activity metrics. Methods: We conducted a survey through the Navitas Life Science annual benchmark of pvnet™, a network of large enterprise companies, and pvconnect™, a network of small and medium enterprise companies, using an online surveying tool during the first quarter of 2021. We collected information on pharmacovigilance activities, including quantitative measures of workload, costs, and key performance indicators, and qualitative data on the effects of the pandemic on product portfolios and operations. Findings: Survey questions were posed to large enterprise (LE) (pvnet™) network members (n=12) and small and medium enterprise (SME) (pvconnect™) network members (n=18). The period of interest is calendar year 2020: January 1 through Dec 31. The date of data collection was March 26, 2021. Descriptive median values of parameter metrics for LE and SME companies include the following: Revenue ($28.4 Billion, $1.6 Billion), number of products (127, 19), and volume of Individual Case Safety Reports (ICSRs) (391 K, 13 K). Small and Medium Enterprise (SME) companies reported greater impact on two survey categories, remote working and employee well-being, than did Large Enterprise (LE) companies. However, LE companies reported greater impact than did SME companies on all other survey categories: effect on strategic priorities, shift in product focus, workload changes, changes in sourcing model, effect on case reporting compliance, effect on business continuity, changes in pharmacovigilance technology strategy, impact of interactions with health authorities, effect on resource capacity, and impact on recruitment.
Fuente: Clinical Therapeutics
