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Job Opening details:-
Company Name :- Indegene
Position Name :-
Company Location :- Bengaluru, Karnataka
Job Category : General jobs
Full Job Description :-
Gap analysis of IFUs in Excel sheet; mapping of contraindications, warnings, precautions and Adverse Events (AEs).
Identification of device specific risks.
Addition of lay language, IMDRF/AHO codes.
Clinical study reports analysis for AEs and their frequencies.
Literature articles analysis – summarization, extraction of AE data.
Commercial data analysis to calculate occurrence rate of AEs.
Create Excel/Word/PDF copies of Risk Evaluation Files containing above data.
Well-versed with MS Office.
Good understanding of Clinical trials, Adverse events, Serious Adverse Events, Adverse Drug Reactions, Adverse Device effects, GCP/ICH guidelines.
Basic understanding of definitions of therapeutic areas like Cardiovascular, Neurology, Respiratory, Renal, Gastroenterology etc.
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