Data Officer

• Manage shared and client-specific mailboxes
• Register vigilance cases in internal tracking systems
• Perform duplicate searches in safety databases
• Conduct initial triage and data entry of vigilance cases
• Code medical information using MedDRA
• Prepare and update case narratives
• Ensure patient data anonymization when required
• Support follow-up requests and case closure activities
• Assess case seriousness and submission requirements
• Submit cases to Competent Authorities, Ethics Committees, Partners, and Affiliates as applicable
• Generate reports and listings from safety databases
• Perform database searches and data extractions
• Support KPI calculations and activity monitoring
• Prepare weekly, monthly, quarterly, and annual activity reports
• Contribute to reconciliation activities and database quality checks
• Support EudraVigilance activities, including ICSR downloads and submissions
• Perform XEVMPD updates and submissions
• Support MHRA, FDA, and other Health Authority reporting activities where required
• Participate in the implementation of new client projects
• Contribute to process optimization initiatives
• Draft and update work instructions, technical agreements, and operational procedures
• Support audits and inspections when needed
• Maintain compliance with applicable pharmacovigilance regulations and company procedures

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Dentistry, or a related scientific field
• Experience in Pharmacovigilance, Drug Safety, Case Processing, Regulatory Affairs, or Database Management is an advantage
• Knowledge of pharmacovigilance regulations and safety databases is preferred
• Pharmacovigilance case processing
• MedDRA coding
• EudraVigilance knowledge
• Database management and data entry
• Microsoft Office Suite
• Reporting and KPI monitoring
• Regulatory compliance awareness
• Strong attention to detail
• Excellent organizational skills
• Critical thinking and analytical mindset
• Effective communication skills
• Team-oriented approach
• Ability to manage multiple priorities and deadlines

• Opportunity to work in an international Life Sciences environment
• Exposure to global pharmacovigilance and regulatory activities
• Professional development and career growth opportunities
• Collaborative and dynamic working environment
• Remote work arrangement