I am Arun, as a dedicated and detail-oriented Drug Safety Associate with over one year of experience in pharmacovigilance and adverse event reporting, I specialize in ensuring drug safety and regulatory compliance. My expertise includes comprehensive case processing. I am passionate about contributing to patient safety and enhancing drug efficacy through meticulous safety data analysis and reporting. My goal is to leverage my skills and experience to drive continuous improvement in drug safety practices and support the successful development of safe therapeutic products.
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Drug Safety Associate-IParexel May 2023 - Nov 2024Hyderabad, Telangana, India*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.o *Ensure timely and accurate reporting of adverse events in compliance with regulatory requirements.o *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. -
Qa InternAurobindo Pharma Ltd Oct 2021 - Nov 2021Hyderabad, Telangana, India
Arun Kumar Education Details
Frequently Asked Questions about Arun Kumar
What is Arun Kumar's role at the current company?
Arun Kumar's current role is Drug Safety Associate at @Parexel international | Ensuring Patient Safety.
What schools did Arun Kumar attend?
Arun Kumar attended Palamuru University, Mahabubnagar, Smt.sarojini Ramulamma College Of Pharmacy, Mahabubnagar, Smt.sarojini Ramulamma College Of Pharmacy, Mahabubnagar.
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