The pharmaceutical industry has made considerable investments in digital safety infrastructure over the past two decades and the results in individual case management are tangible. Safety databases have transformed how individual case safety reports (ICSRs) are received, processed and submitted bringing rigour, speed and scalability to a function that previously resisted both. Yet for all that progress, a significant proportion of the operational work surrounding those systems has not changed in any meaningful way. Aggregate report scheduling, pharmacovigilance system master file (PSMF) management, PV agreement maintenance, medical term query management and affiliate oversight are still largely managed through spreadsheets, shared drives and email.





