Anil Kumar

About Anil Kumar

Perform QC review of Individual Case Safety Reports (ICSRs) literature screening for valid ICSR and non-case reports, and meet quality standards as per the requirement. Processing of Individual Case Safety Reports (ICSRs) from various sources case related information in the safety database. Performing coding of adverse events terms use medical dictionaries such as MedDRA V25.0, and WHO-DD to code products. Responsible for the processing of different types of cases like spontaneous, Solicited, Legal and Partner cases. Data entry of ICSRs in ARGUS database. Data entry of the adverse events including patient’s demographical data, suspect and concomitants, narrative writing, selection and detailing of adverse events, action is taken dechallenge and rechallenge, medical history and diagnostic details. Coding of the suspect and concomitant drugs using the company and WHO-DRUG dictionaries. Coding of verbatim terms using MedDRA for patient history, investigations, product indication and event term.To Screen and review literature articles for safety information related to ICSR, PSUR, Signal detection etc. To Identify valid/potential ICSRs for processing and identifying articles with significant safety assessments. Monitoring of incoming reports from various sources via mailboxes, EudraVigilance, literature searches etc. Perform literature searches as per search strategy, performs data entry of valid cases into the safety database Writing narratives: Create complete, accurate and succinct narratives adhering to established processes. Seriousness determination and causality assessment. Assessing listedness of adverse events (AE) using various labeling documents.

Experience

1. Drug Safety Associate

   ICON plc

   Dec 2022 — Present · Chennai, IN

Education

• Sir C.R.R. College Of Pharmaceutical Sciences

  Master's degree, Pharmacology

  2016 — 2018

• Sir C.R.R. College Of Pharmaceutical Sciences

  Bachelor of Pharmacy - BPharm

  2012 — 2016