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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
Key Accountabilities
- 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 requests
- Supp...