Rohini Dhobale

Background

About Rohini Dhobale

Doctor of pharmacy graduate Presently Working as Pre Clinical Data Analyst where I am dealing with Pre clinical trials Final reports & Protocols raw data in Excel pdf word.Doing conversion and extraction curation of necessary data following CDISC SEND IG & TCG (FDA). The CDISC Standard for the Exchange of Nonclinical Data (SEND) Implementation Guide provides the structures and implementation rules for the submission of data from single- and repeat-dose toxicity studies and carcinogenicity studies. Also I have done manual testing and validation (CSV) for 6 months. I have undergone one year of clinical pharmacist internship during my academics where we Reported ADRs to Pharmacovigilance program of India through vigiflow software. Also I have completed Pharmacovigilance training at Arcolab pvt Ltd where I was trained to identify 4 criteria for ICSR valid case ICH GCP & GVP guidelines Literature review comparison Patient information leaflates Signal generation. Familiar with ARGUS Database.