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

Follow Up Specialist