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.

Responsibilities:

Data Management

  • 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

Regulatory Submissions

  • 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

Database and Reporting Activities

  • Generate reports (summary tabulations) and line listings from safety databases upon request
  • Perform specific database queries to support reporting needs

Experience

  • Bachelor’s or Master’s degree in Pharmacy
  • 1 to 3 years of experience in Pharmacovigilance / Case Management
  • Vigilance case processing and triage
  • Safety database usage
  • MedDRA coding
  • Regulatory reporting activities
  • Case tracking and reporting tools

Soft Skills:

  • English proficiency
  • Analytical mindset and attention to details
  • Ability to manage and structure data
  • Strong communication skills
  • Client‑oriented approach

Data Officer (India)

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