Mamatha Sathyanarayana

Supported the drug development process by monitoring and reporting adverse events and ensuring compliance with regulatory standards. Collaborated with cross-functional teams to collect and evaluate safety data, conducting signal detection activities to identify potential safety concerns. Prepared and submitted expedited and periodic safety reports to regulatory authorities, while also training and

Served as a Drug Safety Operations Specialist, performing case processing activities for adverse events in accordance with ICH-GCP and FDA/EMA guidelines. Conducted seriousness, causality, and expectedness assessments, and processed serious and non-serious adverse event reports. Maintained the safety database, ensuring data quality, and utilized WHODD and MedDRA coding for medical terminology.

Supported the Louisville Metro Department of Public Health with COVID-19 case investigations, contact tracing, and daily patient monitoring. Managed food and factory clusters, investigating cases and communicating with businesses for reporting and contact tracing purposes. Maintained accurate data in the case management system and provided public health advisories and informative resources.

Gained hands-on expertise in end-to-end case processing activities for unsolicited, solicited, and literature reports in Pharmacovigilance databases such as Argus and ARISg. Determined the reportability of cases to local and international regulatory authorities, ensuring timely submission. Performed data entry, quality checks, and coding of medical history, drugs, and adverse events using MedDRA a

Worked on various research projects in dentistry and managed activities associated with the initiation and completion of clinical trials. Communicated with patients to provide education regarding investigational studies and ensured patient safety and compliance with good clinical practices. Collected and maintained clinical data, case report forms, and regulatory binders, contributing to a publish

Worked on clinical documentation, ICD-9-CM medical coding, patient chart reviews, and auditing in the medical records department. Performed CMS core measure data abstractions and analysis using Truven Health Analytics, PSI, and HAC reports. Contributed to HCAHPS and Leapfrog hospital surveys and quality improvement activities.

Participated in the USDA project 'Empowering Youth with Nutrition & Physical Activity', performing data collection, entry, and statistical analysis. Conducted environment assessment surveys and applied principles of program planning, development, and evaluation. Assisted in a smoking cessation program by performing data entry and analysis, and provided behavioral group counseling.

Carried out various dental procedures including cavity filling, root canal treatment, dental extractions, scaling, and polishing. Assisted in research on caries prevalence measurement and clinical testing of dental materials. Provided education to patients on oral care and dental hygiene.

Provided comprehensive dental treatment to patients, including cavity filling, root canal treatment, dental extractions, scaling, and polishing. Organized school oral health check-up camps, providing treatment and education on oral care and dental hygiene. Offered pre-treatment and post-treatment financial guidance and follow-up to patients.

Completed a Master of Public Health degree. The program was CEPH accredited, focusing on public health principles and practices.

Obtained a Bachelor of Dental Surgery degree. This program provided comprehensive training in dental practices and patient care.