Senior Drug Safety Associate

Year Hyderabad, Telangana, India

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Hyderabad 2 to 4 years Full Time

Pharmacovigilance

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

On premise

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.

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