Clinical Trial Consultant II

Senior Safety Associate (Clinical Trial Consultant) 6 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 cases Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders Perform retrospective quality checks on processed cases Independently 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 reporting Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management Provide investigation details into late regulatory reporting of CT cases

Essential Skills and Qualifications Required: Knowledge of Global and local safety regulations Excellent written and verbal communication skills Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance Strong 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 field Experience : 4+ years experience in pharmacovigilance

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