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As part of the global post market surveillance reporting team, the new colleague will be facilitating business data collection and reporting efforts and generating periodic product post market surveillance reports. This includes regular interactions with area subject mater experts to ensure data is collected, documented and analyzed in a timely and accurate manner. The person will use local and global systems to collect various post market information such as complaints, field corrective action and CAPA data. In addition, the QE will work with subject matter experts to analyze product related data and document conclusions of the review activities.
Job Responsibility:
Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports
Analysis of post market data and reviewing completed reports with business partners
Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance
Maintain, archive and completed controlled quality records
Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners