Key Accountabilities

General

• Maintain expert-level knowledge of safety profiles, labeling, and global regulations
• Lead development of project-specific procedures and workflows
• Provide technical guidance to junior team members
• Prepare for and participate in audits and inspections
• Analyze metrics and drive continuous improvement
• Collaborate with cross-functional teams on safety deliverables
• Identify risks and recommend mitigation strategies
• Ensure compliant documentation and archiving

ICSR Processing

• Lead project management including safety procedure development and database setup
• Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)
• Manage case documentation including narratives, reconciliation, and quality control
• Generate safety reports, listings, and respond to ad hoc reque...