Within 5 weeks in Q2/2009, I designed and implemented a new literature support process for periodic safety reports by Novartis Drug Safety.
The service was fully compliant to regulatory requirements and covered all global Novartis drugs (~160) as well as all periodic safety reports to relevant authorities by Novartis Global Drug Safety (PSUR, PBRER, ASR, DSUR). For example in 2012 and 2013, around 1’000 produkt-related literature searches per year were processed by the service (on average 85 per month).
Originally this process had been intended to be an interim solution. But due to its stability, reliability and scalability, it was subsequently expanded to Sandoz (generics) and Novartis Vaccines products, and continued beyond me leaving Novartis in 2014.
| CLIENT: Novartis Drug Safety (as a Novartis employee) | PROJECT TIME FRAME: May – June 2009 (set-up) |
