🛠 Tech Stack

💼 About This Role

You'll manage the submission of individual case safety reports (ICSRs) to global regulatory agencies, ensuring compliance with local and global safety reporting regulations. You'll work with the ARGUS safety database to generate and distribute reports like CIOMS I and MedWatch 3500A while maintaining submission trackers and metrics. This role offers the chance to support clinical trial safety operations in a fast-paced CRO environment.

🎯 What You'll Do

• Monitor Drug Safety inbox for submission acknowledgements
• Generate regulatory reports from safety database (CIOMS I, MedWatch 3500A, XML)
• Prepare and distribute submission documents including Investigator Safety Letters
• Perform case closure and electronic filing of SAE documentation

📋 Requirements

• 2+ years of clinical trial drug safety experience in Pharma/CRO industry
• Knowledge of global safety reporting regulations (FDA, ICH, EU)
• Experience with ARGUS Safety Database
• Experience with EMA EudraVigilance or other reporting portals