Hands-on expertise in start to end of Case Processing (unsolicited, solicited and literature reports) in Pharmacovigilance data bases such as ARGUS, and ARISg.
Data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Oracle Argus Safety Database and performing quality check of ICSRs
Experience in reviewing medical and scientific literature for safety information
Review and monitoring of compliance through monitoring ensuring implementation of Corrective and Preventative Action (CAPA) plans.
Proficient in working with clinical development teams and in clinical study environments.
Write case summaries of gathered information into a concise clinical narrative, assessing causality, and writing CIOMS comments if required
Code adverse events and drugs using MedDRA and WHO Drug Dictionary
Generate queries to obtain missing case information and clarifications in Electronic Data Capture and analyze, and present scientific and medical data in verbal and written format
