Selected Associates

A sample of Associates we have in our network is presented below.

QC and Submissions Coordinator

This Associate has a degree in Pharmacy from a leading Indian University and an MSc in Bioinformatics from a leading UK institution. He has worked for a number of CROs in both India and the UK together with a leading blue chip biotech company based in the UK and has over 5 years experience in PV work.  He is expert with most leading PV database management systems and has supervised the work of a large team of case processors.

Senior Case Processor

This Associate has a degree in pharmacy and an MSc in Pharmaceutical Sciences. She has worked in pharmacovigilance for 5 years and has considerable experience in all aspects of case management including: data entry, coding, QC, scientific review and case submission. She has had responsibility for processing both pre approval (clinical trials) and post approval (spontaneous, literature and regulatory) cases and has experience in reporting ICSRs and SUSARs in all ICH regions. She has been responsible for writing DSURs, PSURs and signal detection reviews and she is familiar with the main drug safety database management systems and their Gateways and has had responsibility for basic administration of these systems.

Junior Case Processor

This Associate has a degree in pharmacy and has worked in pharmacovigilance for 3 years.  He has experience in all aspects of case management including: data entry, coding, QC, scientific review and case submission for post approval (spontaneous, literature and regulatory) cases and has experience in reporting ICSRs to most European Authorities. He has also co-written numerous PSURs and taken an active role in signal detection reviews.