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.
Responsibilities / Authorities
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