Suganthi K.

3+ years experience in preparation of clinical study report (inclusive of pharmacokinetic and statistical) and protocol. Basic knowledge of drug safety and pharmaceutical vigilance procedures Exceptional knowledge of FDA, EU and ICH guidelines Skilled in review, analysis and processing of data’s from clinical trials Sensible knowledge to monitor and track Serious Adverse Events, serious and non-serious adverse drug reactions and other medically related project information Knowledge of eCTD Validator, eCTD Viewer and Life Cycle Management Experience in Publishing(Bookmarking and Hyperlinking) and Peer Reviewing different types of document like (eg Clinical Study Report, Annual Report, Protocol, Amendments, PSUR, DMF and CRFs. Highly proficient in Microsoft office, Adobe Acrobat and ISI Toolbox. Knowledge in guidance’s proposed by USFDA, ICH, ANVISA, WHO, EMEA and Health Canada.