Sheethal Raina Kommu

Case processer, Data Entry of individual case safety reports (ICSR) and post marketing case reports in LSMV database.

Review and evaluate validity, seriousness and coding of drugs, indications, medical history, laboratory test and adverse drug reactions (ADRs) via various dictionaries such as MedDRA, WHO - DD and CDD

Narrative writing and checking the completeness and accuracy of the data entered in the various fields.

- processed literature and icsr cases in Argus safety database.

-supported various team activities based on project needs.

-participated actively in team meetings and huddles to align with project goals.

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Case processer, Data Entry and Quality Reviewer of ICSR into Safety Database (ARGUS 8.1.2).

Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures and Process all incoming cases in order to meet timelines for both serious and non-serious.

Responsible for coding drugs/procedures/indications and laboratory tests according to appropriate dictionary (MedDRA, Company Product Dictionary, WHO-DD).

Assested general medicine department for diagnosis, vitals monitoring and patient history collection.

Handled ICU and emergency nephrology and ortho cases.

Offered p[atient counselling on medication adherence, life style and prevention strategies.

Provided patient care under supervision in general medicine department.