Requirements & Experience:

• Manage end-to-end safety deliverables within agreed timelines
• Perform clinical assessment and triage of safety information
• Support signal detection, trending, and documentation of rationale
• Draft narratives, summaries, and follow-up requests where needed
• Collaborate with Regulatory, Clinical, QA, and Medical teams
• Maintain inspection-ready documentation and controlled records
• Contribute to SOP updates and continuous process improvement
• Coordinate with Helix stakeholders to deliver outcomes