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Bioclinica – Pharmacovigilance jobs 2021


Location – Mysore

Position :- Drug Safety Associate

Educational Qualification :- life sciences graduates

Job Description

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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