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The Data Officer is responsible for the accurate, timely, and compliant management of vigilance data. This includes safety and administrative data handling, traceability, and integration into internal, client, and regulatory systems.
Job Responsibility:
Manage generic or client-specific vigilance email inboxes
Register initial vigilance cases in internal tracking tools
Perform duplicate searches in client or PLG safety databases
Conduct initial case triage and data entry (including MedDRA coding and narrative writing)
Prepare acknowledgements and follow-up request communications
Perform case follow-up via phone or email
Detect and document vigilance cases
Maintain and update internal tracking tools and client files
Submit clinical and post-marketing cases to Competent Authorities, Ethics Committees, Partners, or Affiliates as applicable
Notify clients according to SDEA / Technical Agreement requirements
Ensure the administrative processing of vigilance files
Generate reports (summary tabulations) and line listings from safety databases upon request
Perform specific database queries to support reporting needs
Requirements:
Bachelor's or Master's degree in Pharmacy
1 to 3 years of experience in Pharmacovigilance / Case Management