Senior Patient Safety Specialist

Parexel · manila, metro manila, Philippines

Location
manila
Job Type
Full-time
Posted
June 22, 2026

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...

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