•Entered preliminary and follow-up information from source documents into the global adverse event database Argus.•Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into adverse event database, review of entered cases for quality.•Monitored standard clinical studies ensuring site compliance with the clinical protocol and ICH/GCP guidelines, ensured data integrity through completeness, accuracy, and legibility. •Participated in the triage process… Show more •Entered preliminary and follow-up information from source documents into the global adverse event database Argus.•Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into adverse event database, review of entered cases for quality.•Monitored standard clinical studies ensuring site compliance with the clinical protocol and ICH/GCP guidelines, ensured data integrity through completeness, accuracy, and legibility. •Participated in the triage process for incoming documents to ensure timely and effective medical and scientific evaluation of adverse event information.•Prepared medical narratives and assign MedDRA terms to adverse events while maintaining consistency with the Argus database.•Submitted CIOMS/MedWatch forms and serious cases to regulatory authorities including the FDA and EU.•Assisted with preparation and review of regulatory reports. Requested follow-up information from consumers, and health care professionals.•Maintained knowledge and understanding of SOPs and current FDA regulations.•Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.•Strong attention to detail, teamwork, and taking initiative.•Processed literature, spontaneous, clinical trial, authority and observational study cases in ARGUS safety database.•Ensured all ICON, Sponsor, and regulatory timeframes were met for the reporting of safety information. Show less

• Conducted a study to determine the efficacy of chromium metal adhesion layers in amorphous silicon carbide neural electrodes with sputtered iridium oxide film (SIROF). • Electrochemical measurements were carried out using a Gamry Instruments. • Collected, analyzed, and interpreted data with minimal supervision. • Compiled data and findings into a capstone lab report.

• Acting as a scribe for Dallas Medical Regional Center. • Documenting history of patient information, review of systems, radiology and test interpretation, medication, exam, and procedures• Work alongside various ED physicians to document patient history of illness, review of systems, physical exam findings, and test results using EPIC medical record system.• Efficiently maintain patient medical charts, increasing patient intake and enhancing doctor… Show more • Acting as a scribe for Dallas Medical Regional Center. • Documenting history of patient information, review of systems, radiology and test interpretation, medication, exam, and procedures• Work alongside various ED physicians to document patient history of illness, review of systems, physical exam findings, and test results using EPIC medical record system.• Efficiently maintain patient medical charts, increasing patient intake and enhancing doctor patient interaction. • Interact with physicians and medical professionals to coordinate policies, procedures, and regulations. Show less