Anisha Rao

Medical Device Vigilance/PV professional. Case monitoring, assessment and reporting of quality and adverse events. Submissions as per local and global regulations, guidelines, and applicable directives. Assigning event codes to the Safety databases. In depth knowledge of safety databases including ARGUS, ArisG and TRACKWISE.

• Performing Quality Control Check on all type of cases to ensure information reported to client is • Raising queries if there is any discrepancy found in case which is entered in data base and solving them in timely manner. • To prepare reports on error rate periodically to identify major area of error fields for reports received via workflow and come up with solution to overcome these errors in that

• Check for source documents in Intake folder. • Redact any inappropriate information as applicable. • Perform duplicate search. • Check if document will process as initial or Follow-up. • Check if case is Valid/Invalid or Non-case/No New information (NNI) report. • Checking for seriousness and listedness of cases. • Differentiating case as periodic or expedited. • Causality assessment of cases.

• Responsible for processing Adverse Event cases to ARIS-g database provided by client. • Responsible for case intake, duplicate check and registration. • 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. • Review of literature articles to identify case safety reports • Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products