Safety And Pharmacovigilance Specialist I
CurrentTrials/Departments as follows: 1) Vaccine Research Center (VRC) 2) Department of Microbiology and Infectious Diseases (DMID) 3) Center for Vaccine Innovation and Access (CVIA) 4) Division of AIDS (DAIDS)Clinical trial contracts awarded under the National Institutes of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH)___________•Compose case/event narratives, data entry, case triage and assignment, aggregate… Show more Trials/Departments as follows: 1) Vaccine Research Center (VRC) 2) Department of Microbiology and Infectious Diseases (DMID) 3) Center for Vaccine Innovation and Access (CVIA) 4) Division of AIDS (DAIDS)Clinical trial contracts awarded under the National Institutes of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH)___________•Compose case/event narratives, data entry, case triage and assignment, aggregate reports, line listings, reconciliations, and coding of event term, concomitant medications, and past medical/surgery history.___________ o Vaccine Research Center (VRC), Department of Microbiology and Infectious Diseases (DMID), Center for Vaccine Innovation and Access (CVIA), Division of AIDS (DAIDS). o Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSARs) processing utilizing Argus tenants, Medical Dictionary for Regulatory Activities (MedDRA) coding, Medidata Rave, electronic data capture (EDC) platforms. o Evaluate case information from clinical sites to construct case narratives and enter into the safety database. o Configure/abstract protocols using Argus console. o Create and maintain DMID’s Configuration Requirements Specifications (CRS) document. o Utilize SAS enterprise guide to perform protocol reconciliation duties and interim duties for line listing and aggregate reports. o Assist in monitoring and triaging the safety inbox and enter follow up and initial cases in Argus. o Track and process pharmaceutical and Data Management Center queries. o Support ongoing projects for detection, correction, and resolution pertaining to discrepancies. o Train new and established colleagues, as needed, for all the above-listed duties. Show less