Tejasri Peta

Senior Medical Safety Analyst

• Job Details:Evaluated and QC of serious adverse events / post-marketing adverse events pertaining to oncology to ensure accurate and consistent data entry and processing from source documents, with emphasis on regulatory timeliness and quality. Ensured accurate and consistent coding of medical history, drugs, and adverse event terms.

Drug Safety Scientist

• Job Details:Conducted preparation, review, and analysis of aggregate reports, including PADER, PSUR, PBRER, and ACO. Generated NDAs, PSURs, CIOMs, and summary tabulations from the Argus database. Analyzed clinical trial and post-marketing surveillance data for serious adverse events (SAEs) and adverse drug reactions (ADRs). Prepared narrative sections detailing individual ADR cases and summarizing various ADRs. Collected safety and efficacy data from clinical trials, preclinical studies, spontaneous reporting systems, and literature. Wrote comprehensive sections on introduction, safety data, conclusions, and recommendations based on clear data findings. Ensured timely submission of reports to regulatory agencies such as EMA and FDA in compliance with guidelines.

Clinical Data Specialist