Drug Safety Associate

• Support handling of serious adverse events (SAEs) in clinical trials and spontaneous market reports
• Ensure collection, assessment, and entry of safety cases into the safety database according to SOPs and regulatory requirements
• Review cases and draft adverse event and serious adverse event report narratives as required
• Code adverse events, medical history, and concomitant medication
• Support SAE reconciliation and DCF handling
• Manage correspondence and archiving
• Assist with EudraVigilance registration and related matters
• Participate in relevant project groups and meetings
• Provide internal support to relevant departments
• Update safety-handling templates for studies and projects according to SOPs
• Contribute to developing routines that improve work at TFS
• Stay informed about laws, directives, and guidelines concerning SAE and pharmacovigilance handling and reporting