Rathnam Rakesh

Drug Safety Associate- i @Parexel

Hyderabad, IN

Accurately receive, triage, and document adverse event reports from various sources, including healthcare providers, literature, and clinical trials.Conduct initial assessments to determine the seriousness and expectedness of adverse events.Prepare detailed case narratives, ensuring all relevant medical and safety information is captured.Enter case details into the safety database, ensuring completeness and accuracy of all fields.Ensure accurate and timely entry of adverse event data into safety databases.Ensure timely and accurate reporting of adverse events in compliance with regulatory requirements.Perform initial evaluation and assessment of adverse event reports, determining seriousness, expectedness, and causality.Review medical records, lab results, and other relevant documents to support case assessment.Identify and request missing information necessary for case completion.Prepare and submit ICSRs to regulatory authorities within required timelines, adhering to global regulatory standards (e.g, FDA, EMA, MHRA).Manage the end-to-end process of ICSR intake, including data entry, assessment, and reporting.Ensure the accuracy of data entered into the safety database and conduct regular audits to maintain data integrity.

Kakatiya University (University College of Pharmaceutical Sciences)

Bachelor of Pharmacy - BPharm