Tata Consultancy Services
Website:
tcs.com
Job details:
Role: Follow Up Specialist
EXP : 2-4 Years
SKILLS:
End-to-End Safety Case Processing (Spontaneous, Solicited, SUSAR)
Case Intake, Data Entry, Case Triage, and Follow-Up Activities
Adverse Event Reporting and ICSR Processing
Job description:
Perform ICSR submission activities to different geographies via electronic, semi-automatic and manual mode.
• Perform submission activities within agreed timelines with high quality with adherence to regulatory guidelines and
applicable standards, and processes.
• Perform other functional duties associated with local case reporting/ E2B; produce CIOMS/ Med-watch and fax/email,
distribute, and upload to document storage.
• Regular interaction with internal stakeholders and external stakeholders.
• Escalates unresolved issues appropriately as per the agreed escalation process.
• Monitoring and prioritizing cases for distribution.
• Assess the reportability requirements for each product.
• Perform/request causality assessment, as required per the regulation.
• Get the translation of documents from vendor, as required
• Review the reports scheduled by the client safety system.
• Confirm the accuracy of the scheduled reports against current reporting references and the reporting matrix.
• Mark report for non-submission as applicable.
• Monitor reports electronically transmitted until confirmation of successful transmission is acknowledged.
• Handling negative acknowledgements.
• Maintenance of submission tracking data of local and foreign reports.
• Perform reconciliation, and document & track compliance related data. Reconciliation activity includes maintenance
of records pertaining to number of cases for submission & submission status with date & time within specific intervals.
• Coordinate with different local affiliates to ensure timely submission to local regulatory authorities.
• Adding/updating the correct submission date in the database.
• Updating/Verifying late reason for late reports in the database.
• Participating in regulatory intelligence activities as and when required.
• Ensuring that the reporting rules are configured and working as expected.
• Ensure compliance with global & local procedural documents, processes & procedures.
• Providing training and mentorship to new joiners.
• Handling Submission Mailboxes as required.
Interested in Mumbai location candidates are requested share updated CV with below details on the mentioned mail id - s.laharika@tcs.com
Click on Apply to know more.