Patient Safety Specialist

Contenido de trabajo

Provides advanced technical assistance on preparing lifecycle management of Patient Safety Enablement processes and technologies which meet the project objectives and local regulatory guidelines. Applies a range of analytical processes and reporting tools and uses relevant software to support projects. Provides solutions to a variety of technical problems of moderate scope and complexity.

Job Description

• Reviews summary safety documents for accuracy, completeness and validity prior to regulatory submission
• Prepares Safety Surveillance Reports, regulatory summary reports, and other customised reports required to support safety surveillance activities
• Evaluates safety data requests from internal and external sources
• Works with safety surveillance personnel to prioritise requests, then obtains data directly or requests formal programmatic data queries
• Supports Patient Safety Medical Director in data review and/or table presentation for formal regulatory submissions or ad hoc safety requests
• Supports Team Leader in preparation of data for Safety Surveillance Group meetings
  
  

Qualification

• Bachelor’s degree in science/healthcare-related field
• Sound understanding of principles and concepts within own specialist area
• English: Conversational