Linda A. Nielsen
Linda A. Nielsen is M.Sc. Pharmacy with a post graduated diploma in Pharmacovigilance. She has been with Billev Pharma since July 2018 as Pharmacovigilance Manager and Deputy QPPV.
She has more than 10 years’ experience with Pharmacovigilance from both headquarters and affiliates within the following areas:
- - Signal detection
- - Literature surveillance
- - Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR) and Risk Management Plans (RMPs) writing
- - Case handling (scientific review as well as operational tasks)
- - Maintenance of SOP system and PSMF.
In addition, she has experience with clinical trial supply and medical information.