Drug Safety Associate

• Receive, scan, and document pertinent clinical information in compliance with SOPs, protocols, and applicable legislation
• Work with internal and external clients to request additional information or clarification
• Review source data documents, including visit report/PIR reviews
• Triage adverse event information and product quality complaints according to client needs
• Enter and submit adverse event information and product quality complaints into program-specific databases
• Sort and file incoming documents
• Perform quality checks on adverse event reports according to work instructions
• Assist with and/or perform source data verification checks
• Screen medical and scientific literature for safety information
• Prepare reconciliation reports, transcription translations, and redaction activities
• Prepare and conduct solicited follow-up letters and data clarifications
• Assist and participate in the non-conformance/CAPA process
• Perform other assigned duties and tasks as required