Responsibilities/ AuthoritiesAs an Intake and Assessment Specialist, I processed receipts from the corporate safety database, performed case creation for various studies, reviewed and entered mandatory fields, and reported issues to team leads. Conducted self-quality checks, managed source documents, and ensured compliance with SOPs.In the role of Safety Reviewer Serious, I reviewed attached source documents, added missing information to ICSRs, encoded verbatim terms using MedDRA, and assessed and coded events post consultation. Managed suspect and concomitant products using safety databases, evaluated labelling information, and addressed validation and e2b checks for comprehensive work completion.

Performed PIER Reconciliation using the PIER application, compared client and ICON data for assigned studies, and wrote queries for accurate patient information. Additionally, I managed data loading, evaluated discrepancies in scan dates, modalities, anatomy, and visit names, and ensured the removal of extra data from the database. I also conducted IDT Reconciliation, assisted in Image Data QC, and generated reports through MIRA. Reviewing PHI files, I highlighted identified PHI, updated the study tracker, and sent files to the corelab team. Lastly, I engaged in Data Forecasting for Medical Imaging studies, addressed issues promptly, and organized daily tasks for timely completion.

**Medical Service Associate - Single Case Support (SCP):**- Addressed letter queries in multiple formats during case processing and reported errors to leads.- Generated line listings and reports using the corporate safety database.- Distributed individual SUSAR to the clinical team and updated literature acknowledgment in Oracle Argus.- Sent literature acknowledgment emails after completing database work and ran timeline-based priority reports.- Shared generated priority reports internally and externally.- Updated the production tracker monthly and communicated with the manager.**Medical Service Associate - Aggregate Safety Reporting (ASR):**- Coordinated with various stakeholders for preparation of Aggregate reports like PBRER, DSUR, PADER, WAIVER, and semiannual SUSAR.- Created module documents in CARA for aggregate reports and generated business partner details from the LEAD database.- Requested and provided supporting data such as sales and signal logs for milestone dates.- Generated preliminary/final line listings using system functionality (Argus/LSRA).- Produced preliminary/final EOI listings for PBRER.- Created draft publications in CARA PRISM and distributed finalized semiannual SUSAR reports through email and Veeva Vault Verity database.