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Key Accountabilities:
General
Maintain expert-level knowledge of safety profiles, labeling, and global regulationsLead development of project-specific procedures and workflowsProvide technical guidance to junior team membersPrepare for and participate in audits and inspectionsAnalyze metrics and drive continuous improvementCollaborate with cross-functional teams on safety deliverablesIdentify risks and recommend mitigation strategiesEnsure compliant documentation and archivingICSR Processing
Lead project management including safety procedure development and database setupCoordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)Manage case documentation including narratives, reconciliation, and quality control
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