Bioclinica Job OPENINGS DETAILS
Location – Mysore
Position :- Drug Safety Associate
Educational Qualification :- life sciences graduates
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. Other responsibilities:
Following up with sites regarding outstanding queries.
• Follow up on reconciliation of discrepancies.
• Follow departmental AE workflow procedures.
• Closure and deletion of cases.
• Mentor and guide the activities of the Dug Safety
Associate. High level of proficiency al all workflow tasks.
• Perform any other drug safety related activities as assigned.
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