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Data Safety Associate

Job Location: Bengaluru

Job Number: 3195


- Job description

Overall Purpose of the job;
Responsible for prioritization and creation of cases in the global safety data base, identification of duplicate cases, complete data entry accurately.;
• Access the designated e-mail box(es) / case receipt tool;
• Create/prioritise cases based on regulatory day and reporting requirement.;
• Perform duplicate check against the safety database for all individual case safety reports to identify case reports already existing in the safety database for that patient.;
• Determine whether the case would be an initial report or a follow-up to a report already available in the database and create initial case reports as relevant.;
• Perform Medical coding in the Safety database as required.;
• Archive all source documents and correspondence mails relevant to case mails in individual case folders in the source document archiving tool.;
• Acknowledge the safety information to the sender.;
• Enter all relevant data into the safety database based on the information available in the source documents.;
• Provide a narrative for each case, which reflects the safety data and is in accordance with client Guidelines and SOPs.;
• Perform validation of the data for each case and make any corrections as needed.;
• Submit the case safety reports to subsequent step in the workflow.;
• Generate queries for missing information and inform the Medical/Scientific reviewer to validate queries.;
• Review the responses to queries when received and update the safety database as required.;
• Ensure compliance to client SOPs, conventions and guidelines for all activities performed.;
• Promote/participate, as appropriate, internal and external
Degree in Healthcare Science Preferred, minimum requirement post graduate degree in life science

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