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  • Senior Drug Safety Associate
    Hyderabad 2 to 4 years Full Time

    Department

    Pharmacovigilance

    Education Qualification

    Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. Fluency in English.

    Mode of work

    On premise

    Job Description

    • 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
    • Literature Search
    • Full data entry including medical coding and safety narrative
    • 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)
    • Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
    • Following up with sites regarding outstanding queries.
    • Follow-up on reconciliation of discrepancies.
    • Follow departmental AE workflow procedures.
    • Closure and deletion of cases.
    • Perform submission activities when trained and assigned.
    • Understanding and application of good documentation.
    • Perform any other drug safety related activities as assigned.
    Apply Now
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