G Navya Email and Phone Number

Review source documents attached to the ICSRs of the assigned cases by viewing or printing them.Review all data entered in the ICSR and add missing information based on the source documents.Encode verbatim terms using MedDRA dictionary-controlled fields. Verbatim events are assessed for entry and additional events if required are coded post consultation with MRSP.Enter/Review appropriate suspect and concomitant products using data base product dictionary and WHO drug-dictionary.Responsible for auto narrative for initial version cases. Write narrative summaries for assigned follow-up cases.Attach appropriate queries for missing/ discrepant information and add follow-up letter as per SOPs.Responsible for completing the validation checks, ICSR checks and lock and route the cases for submissions.Plan, organize and manage daily work to meet service level timeliness and deliverablesWork with the safety review team lead / Manager to escalate issue or tasks outside the normal scope of work.

Selects the receipt from the corporate safety database for processing.Perform the creation of spontaneous, clinical (interventional studies, non-interventional studies), E2b, LM, and literature cases.Reviews the source/ case, check for follow-up or create a new case by entering the minimum mandatory fields as per the client manual.Responsible for intake and assessment process; and if there are issues with the provided information, the team leads are informed.Review and self QC all forms and documents pertaining to a case for duplicates, irrelevant information, legibility, redaction and splitting of documents and request for rescanning / split if required.Splitting of bulk lime listing and site query response batches.Sending the queries to senders based on the hold request and following-up the requests.