Dr. Tadaveni Sai Koushik

• Performing quality control checks of ICSRs (Any errors/discrepancies noticed during QC activity were documented and will be shared with the individual who performed the Data entry of ICSR).
• Literature review: Weekly review and validity assessment of articles.
• Regulatory submissions and submissions to the partners
• Follow-up activities of ICSR
• Quality meetings with ICSR team.
• Aligned work processes with bodily mechanics to improve job function which reduced workplace repetitive movement injuries.

Experience in management of Individual Case Safety Reports (ICSRs) of all case types (post marketing cases including literature cases/CT cases) which include:

• Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities.
• Conducting duplicate searches prior to book-in and identifying potential duplicates. Managing duplicate search of cases appropriately. Book-in of ICSRs into the safety database.
• Data entry of ICSRs – spontaneous, literature, partner cases, legal cases, PMS, regulatory and Clinical trial cases (Cancer trials).
• Performing quality control checks of ICSRs (Any errors/discrepancies noticed during QC activity were documented and will be shared with the individual who performed the Data entry of ICSR).
• Literature experience: Review and validity assessment of articles. Processing literature cases from medical journals including abstracts, poster presentation, literature summary cases and full text articles and communicating with the authors for the required information on the articles.
• Regulatory submissions and Follow-up activities.
• Assisted in the development and implementation of training materials, contributing to the ongoing education of fellow Drug Safety Associates.
• Improved patient safety by accurately reviewing and processing adverse event reports.

• Initial Literature Screening of citations from PUBMED & AdisInsight, Validity assessment, performing Duplicate search, Follow-up activities, Ordering Full Publication from authenticated sources, requesting Translations, review of Full Publication.
• Performed case management including duplicate check, seriousness, expectedness, data entry, narratives, Follow up, QC.
• Data entry in ARGUS (Verification of coding in different ARGUS tabs like medical history, lab data, products coding included the suspects, co-suspects, and concomitants and adverse events. Any errors/discrepancies noticed during QC activity were documented and will be shared with the individual who performed the screening to foster continuous improvement.)
• Proficient in using MedDRA and WHO drug dictionary.
• Performing Quality Check of Adverse Events, Serious Adverse Events based on approved case processing metrics.