• Proficient in testing and debugging with tools like Postman to ensure accurate, standards-compliant adverse event forms.• Skilled in Argus Console configuration, including user settings, expedited reporting, product setup, MedDRA and WHO-DD upgrades, and code list updates per E2B codes.• Developed Adverse Event Reporting Form used by clients to submit Individual Case Safety Reports (ICSR) in the database.• Expertise in interacting with safety databases (Argus, PVCM) using SQL for testing purposes.• Configured structured forms (CIOMS, MedWatch, and custom client forms) using AI tools to enable automated data parsing into safety databases.• Hands-on experience with safety databases like Argus, PVCM, Veeva Vault, and Mosaic.• Proficient in JIRA for tracking, resolving, and collaborating on testing activities while maintaining audit trails.• Skilled in IQ/OQ drafting and execution to support Computer System Validation (CSV) processes.• Managed client portfolios, including leading firms such as Eli Lilly, Lundbeck, Organon, Regeneron, Merz, and Jazz.• Expertise in analyzing patient safety data and training Large Language Models (LLMs) for unstructured data parsing using techniques like Named-Entity Recognition (NER).• Prepared safety reports, including PSUR, DSUR, and PBRER, using automation scripts.• Skilled in deploying system builds on servers in compliance with IQs and Software Development Lifecycle (SDLC).• Proficient in using Linux-based systems to manage and interact with servers.

• Processing Individual Case Safety Reports (ICSR's) of both non-serious and seriouscases from various origins including spontaneous, solicited programs and E2B cases.• Conducting duplicate search, triage and then entering data into the safety database(Argus and Mosaic) in accordance with customer specific guidelines and companystandards.• Coding of adverse events (AE) and medicinal products into safety data bases using MedDRA and WHO-DD.• Understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs),global drug/biologic/device regulations, Good Clinical Practice (GCP), ICH guidelines,Good Pharmacovigilance Practice (G V P) modules, study/program plans and the drugdevelopment processes.• Expertise in writing narrative of various ICSR cases into safety databases.• Expertise in processing Product Complaints details into ICSR using product complaintsoftwares such as CATTOOL and CIRE.• Expertise in maintaing the ICSR quality as contributed in various Qullity Checks ofICSRs to assure the desired quality.

• Tagging the patient safety data to improve the accuracy of various safety data Modelsusing machine learning tools.• Analysing the Literature Cases to extract the patient safety data using various AItools.• Proven ability to create and execute test cases, document test results, and providerecommendations for process improvements.• Experienced in working with cross-functional teams, including data management,quality assurance, and regulatory compliance, to ensure alignment in testingmethodologies and data integrity.