Our multinational client is looking for a KPI Expert to support a drug safety project.
- Create daily and weekly Case Handling Process update reports
- Prepare advanced search reports in Sapphire and Business Objects reports based on inputs from TL, SME, PL, PM
- Ensure compliance with global and local procedural documents and local implementation of the client and internal policies, processes, and procedures
- Perform all activities within the required timeframes to ensure regulatory compliance
- Feedback errors found in expedite and non-expedited cases to team leaders
- Ensure the development of the project
- Establish a well-developed customer relationship through the Safety Operations Regulatory Compliance (SORC) team
- Complete performance data check and assessment
- Perform internal quality check
- Perform post-closure quality and process control on closed cases
- Perform compliance data evaluation
- Qualified to degree level in bio-sciences or an appropriate healthcare or pharmaceutical industry background.
- Knowledge of medical terminology
- An understanding of the principles and concepts associated with the Patient Safety case-handling process, including regulatory reporting requirements for single case expedited reporting and periodic updates.
- Patient Safety policies, processes, and procedures knowledge.
- User-level IT knowledge or above
- 2+ years of experience in Pharmacovigilance
- Relevant degree
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