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Drug Safety Specialist

Company: Beacon Hill Staffing Group
Location: Bethesda
Posted on: January 12, 2022

Job Description:

Requirements:REQUIREMENTS--- M.D. or D.O from an accredited institution--- Infectious disease and/or oncology sub-specialty highly preferred--- Must have knowledge of GCP and ICH guidelines--- Drug development/clinical trial experience essential--- Knowledge of CTC and/or MedDRA coding preferred--- Experience leading clinical and cross functional teams is a plus--- Must have excellent oral, written, presentation and computer skills--- 2+ years of pharmaceutical or biotech industry or academic experienceRESPONSIBILITIES - Manage and process all SAEs as per project specific instructions - Document Control: maintain electronic files for department, perform file case searches, maintain file room for the department and use department databases to track, manage and control issued documents; assign various tracking numbers - Track and process assigned pharmaceutical and Data Management Center (DMC) queries - Assist in the preparation of contract-required reports - Generate specified data reports from the safety database as requested - Process and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as required - Distribute Safety Information according to project specific requirements - Assist in processing of MedDRA coding tasks - Perform QC on AE submissions

Keywords: Beacon Hill Staffing Group, Bethesda , Drug Safety Specialist, Other , Bethesda, Maryland

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