Komal Mohite

• Efficiently handling Oracle Argus and PVCM Safety Database
• ICSR Activities: triage intake, data entry, QC of CT SUSAR, spontaneous cases, follow-up report/amendment reports, and query responses
• Comprehensive safety narrative writing for CT cases
• Submission activities
• Aggregate reports (AGR) activities:

1. Collection of line listings from safety database (PVCM) for preparation of aggregate reports and signal detection reports, and coordinate activities such as collecting data for report planning, developing strategies, and leading meetings for comment resolution.

2. Preparation and finalization of PSUR and PADER schedule for approved products as per DLP.

3. Review Periodic Safety Update Report (PSUR/PSUR in PBRER format) and Risk Management Plan.

4. Request and collate prerequisites for the preparation of reports from RA, Clinical team and ICSR team.

5. Preparation and finalization of responses to regulatory queries, suggestions, and observations on submitted reports.

6. Preparation and finalization of PSUR and PADER schedule for approved products as per DLP.

7. Literature search activity, literature screening, and AOI report for preparation of aggregate reports.

• Efficiently handling Oracle Argus and Aris-G Safety Database.
• Maintain log of source documents and other communications.
• Responsible for triage intake, data entry, QC of CT SUSAR, spontaneous cases, follow-up report/amendment reports, and query responses.
• Performed extraction of medical records (hospital, discharge summary).
• Responsible for sending follow-up queries to the site and following up regarding outstanding queries.
• Responsible for comprehensive safety narrative writing and checking the completeness and accuracy of the data entered in the various fields.
• Responsible for tracker updating and SharePoint updating.
• Perform any other drug safety-related activities as assigned.
• Experienced as a QC reviewer of cases to ensure 100% accuracy of cases.
• Line listing and workflow status check.
• Submission activities.
• Review the Risk Management Plan.
• Backup for drafting aggregate reports, including Periodic Safety Update Reports (PSUR/PSUR in PBRER format), Risk Management Plans (RMP), and Signal Detection Reports.

• Efficiently handling Sapphire database.
• Triage and classify individual case safety reports (ICSRs) for report type and seriousness, and priorities ICSR according to regulatory requirements.
• Conduct duplicate searches to determine the correct action for the ICSR (Initial or follow-up).
• Experienced in handling ICSRs of various types (spontaneous, solicited, pregnancy cases, PQC reports, Health Authority cases, E2b cases, social media cases, etc.).
• Experienced as QC reviewer of cases to ensure 100% accuracy of cases.
• Manual acknowledgement of receipt as required.
• Maintain good working knowledge of the procedures and guidelines.
• Perform workflow management activity for the smooth running of the workflow.
• Kept the work log updated and completed the requisite trackers.