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Ensured that medical records and health information were accurate, complete, and secure.
Added novel safety data analysis in 2024.
Reviewed charts and flagged incomplete or inaccurate information.
Analyzed clinical AE reports.
Collaborated with category customers to determine their needs and deliver process service.
Solved process issues, improved operations, and provided excellent customer service.
Achieved commendation for no critical safety issues.
Assessed safety concerns in post-marketing reports.
Advocated for process improvements that resulted in a 37% decrease in the review timeline without sacrificing quality standards.
Achieved a 42% precision increase.

Conducted regulatory audits.
Dedicated to learning, growing, and succeeding in Miscellaneous.
Boosted compliance rates through meticulous safety data analysis.
Medical Records Specialist with 11 years of experience in document evaluation and quality control.
Conducted safety data reviews.
Consistently met submission deadlines.
Collaborated with cross-disciplinary teams.
Astute Medical Reviewer known for conducting regulatory meeting presentations and securing approval for 6 new medication launches. Demonstrates strong cross-functional leadership and an ability to synthesize complex data for stakeholders.
Dedicated performer with experience processing subpoenas and court orders.
Bilingual achiever with experience scanning and indexing medical records to the correct chart.

Co-authored regulatory submissions leading to timely approval of 13 new drug applications (NDAs) within 6 months.
Optimized the review process for clinical trial reports, reducing the average time to complete reviews by 34% with zero compromises in quality.
Documented and resolved program which led to category.
Updated and streamlined medical review SOPs, improving overall operational efficiency by 69% and reducing review turnaround time by two years.
Created a risk-benefit analysis model for identifying safety signals in large datasets, reducing undetected adverse events by 57%.
Conducted in-depth analysis of adverse event reports, discovering a previously unrecognized drug safety signal that led to metric.
Led departmental workshops on clinical data interpretation, increasing technical knowledge of staff and resulting in 83% improvement in error detection.
Implemented new training modules on GCP compliance and review methodologies, reducing review processing time by 54% and enhancing reviewer skillsets.
Key contributor in regulatory meetings, presenting data-backed safety recommendations that led to the successful approval of Microsoft Excel in Raleigh.
Developed and launched a clinical protocol review training program for 9 junior reviewers, improving clinical data accuracy by 80% within the first quarter.