Komal Pathania

Background

About Komal Pathania

Well versed with Drug Development Process including different phases of clinical trials, History of Pharmacovigilance, Definitions and Terminologies used in contex to both Individual Case Safety Report(ICSR) and Aggregate Reports. • Trained in preparation of aggregate reports including-PBRERs/PSURs and PADERs -DSURs -Addendum to PBRER/PSUR -Ad hoc reports -ACO • Trained in MedDRA coding in accordance with "MedDRA Term Selection: Points to Consider" • Maintaining an excellent knowledge of the safety profile of assigned drugs, reference Safety Information, aggregate reporting conventions and guidelines, client procedures and international drug safety regulation including-ICH guidelines on safety and efficacy -GVP modules and FDA guidelines • Performed Seriousness, Expectedness and Causality assessment for numerous cases with a great deal of attention to all the significant and relevant parameters.