Arghyadeep Bose

Senior Associate

Wipro Limited

10.2021 - Current

AER Reporting - Investigated and drafted FDA MDR (Including both harm and no-harm reports) reports via both E-submitter and Trackwise systems. Simultaneously updated SAP records for the said report submissions under various SAP transactions which also included removing and creating attachments with submission reports and Acknowledgement files.
MIR Reporting - Drafted and submitted MIR reports for Medical device equipment manufactured by the client company with respect to the countries in the European union and also completed SAP record updates for the same.
Country Specific Reporting - Reported MDRs and MIRs for various country specific reporting areas including Japan, Malaysia, Germany, Denmark etc. Also, updated SAP records for the same simultaneously for MDR creations and also functional inbox roles.
Malaysia Reporting Task Update - Performed operations such as closing and creating SAP tasks (including verbiage composition and addition) for reports specific to In-country representatives in Malaysia for medical device equipment. Job role here also included sending MDR reports to the country via Email and other electronic submission systems.
Japan Reporting Task Update (Current Responsibility) - My job roles here included parsing and compiling of submitted MDR and other Medical device reports from the SAP systems databases and sending them to the in-country representatives in Japan for retrieval an evaluation. I also updated SAP records under the UNO Japan task sections which included verbiage creation, addition and closing/opening of tasks.
Tasks on Client's Requests - Worked on various different tasks which were on behalf of the Ad-hoc requests from the client's end. Some of these tasks included Completion/opening of SAP records upon examination of the record types. Also worked on specific peer reviews and quality checking for the tasks done by other associates.