Clinical Trial Consultant II

Senior Safety Associate (Clinical Trial Consultant) 12 month contract Must be able to work on a W2 Remote, EST hours Job Scope: Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries. Key Responsibilities Triage, Intake, case entry and QC of ICSRs originating from organization sponsored studies or other assigned casesIncludes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholdersPerform retrospective quality checks on processed casesIndependently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reportingReview and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data ManagementProvide investigation details into late regulatory reporting of CT cases Essential Skills And Qualifications Required Knowledge of Global and local safety regulationsExcellent written and verbal communication skillsExperience in ICSR processing in safety database systems such as ArisG, Argus and VeevaUnderstanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for PharmacovigilanceStrong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required Education And Experience Requirements For Job Education : Bachelor’s degree in science or healthcare related fieldExperience : 4+ years experience in pharmacovigilance