Company name – BIOCLINICA
Position – Drug Safety Associate 1
Location – Mysore
Essential Duties And Responsibilities
As Quality Check Reviewer
Review data entered in safety database for completeness and accuracy.
Provide quality feedback to team resources
Track and maintain quality metrics
As Case Processor
Responsible for data entry of Individual case safety reports into the safety database.
Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
Process all incoming cases in order to meet timelines.
Full data entry including medical coding and safety narrative.
As Medical Coder
Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).
As Narrative Writer
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.