Sudarshan Gour

Senior Drug Safety Associate

Tata Consultancy services (TCS)

11.2019 - 09.2024

Responsible for full data entry of individual literature, clinical trials case safety reports into database.
Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures.
Full data entry including medical coding and safetynarrative.
Working in Complaint remediation, medical device reporting and quality for Management database.
Proven experience in Complaint’s intake, investigation process, quality check and Final closure as per FDA regulatory norms.
Investigation and reporting of Medical Device Reports for submission to FDA, if incident meets reportable criteria for both malfunction and serious injury.
Complaint history review, device history review, root cause determination, investigation summary writing, and code determination.
Evaluate all information from a clinical and technical perspective to ensure appropriate analysis, investigation, root cause, and quality review engineering document prior to complaint closure.
Finding root cause of the reported allegation to identify the device failure, provide investigation summary report and solution to customer.
Ensure the proper documentation is maintained as per audit requirements and company policies.
As a Medical coder: Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (e.g. MedDRA, company product dictionary, WHO-DD).
As a Narrative writer: Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

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