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Monitoring
Key Responsibilities:
- Monitors timelines for adverse event processing.
- Prepares narratives of adverse events for adjudication by the CEC.
- Collects, reviews and files all clinical study documentation.
Safety Surveillance and Reporting:
- Reviews adverse events reported in clinical study evaluating safety issues and patterns that are identifiable.
- Contribute to the coding of events according to MedDRA or IMDRF standards.
- Assists in preparing clinical study reports of assigned projects for submission to regulatory authorities.
Strategic Impact:
- Supports clinical safety management for all sponsored clinical studies.
- Focuses on drug-eluting balloon catheters.
Cordis
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. At Cordis, teammates bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives.