BethesdaRecruiter Since 2001
the smart solution for Bethesda jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Maryland jobs by following @recnetMD on Twitter!

Bethesda RSS job feeds