To provide support to independent medical safety assessment for Dexcom products by proactively obtaining, reviewing and evaluating additional data and reports containing potential safety information. To support individual case global safety / regulatory reporting compliance. To interact with and provide support to Health Care Professionals and Dexcom patients, who require immediate assistance due to device issues with potential health implications.
- Assure medical validity and provide input to the activities of Customer Advocacy and Quality teams
- Following documented procedures, produce and document medically accurate assessments to include elements such as coding, causality, seriousness, and case narratives.
- Contribute to safety trend analyses and any related periodic review meetings.
- Review and provide input on any complaints regarding serious adverse events. Contact medical professionals for additional information as required.
- Execute medical triage for appropriate causality on investigational assessment documents supporting regulatory reporting.
- Triage and appropriately escalate complaints that require elevated review
- Provide input on responses to adverse events, complaints and mass communications, review internal and customer safety training materials, input into design and interpretation of global post-market safety studies, and evaluate the medical impact of manufacturing issues.
- Ability to interpret company policies and procedures to complete a variety of tasks.
- Knowledge of and clinical experience in field of diabetes and CGM technology are desirable. Experience in Safety Vigilance monitoring and
- Adverse Event case processing/reporting or Quality Assurance are desirable.
- Must be self-motivated, self-confident, and be able to work independently or equally well as a team member. Demonstrated ability for teamwork and collaborative problem-solving.
- Other important qualities include excellent written and verbal communications skills, attention to detail, consensus building and teamwork, planning and implementation skills.
- Fluent English and German
Vacancy Type: Full Time
Job Location: United Kingdom
Application Deadline: N/A