Requirements & Experience:

• Design and support PASS and observational safety studies
• Coordinate with epidemiology and RWE teams
• Ensure regulatory compliance of study protocols
• Monitor study progress, milestones, and deliverables
• Review safety data from real-world sources
• Support regulatory submissions and responses
• Maintain study documentation and reports
• Liaise with external research partners and vendors
• Present study findings to internal stakeholders
• Support inspections and post-marketing commitments