Note: The job is a remote job and is open to candidates in USA. Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to improve health outcomes for diabetes management. The Clinical Customer Advocate 2 role involves providing support for medical safety assessments and ensuring compliance with global safety regulations while assisting healthcare professionals and patients with device-related issues.
Responsibilities
- 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
- Triage and appropriately escalate product complaints that require elevated review and safety signals
- Execute post market surveillance activities in compliance with applicable global regulations, such activities include post market plans, PSUR, CER, literature reviews, design control, and risk management
- 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
- Assist in providing safety trend analyses and any related periodic review meetings
- When indicated, review technical support calls and communicate potential issues with technical support management
- Performs other duties related to the position as necessary as defined in company’s SOPs or requested by his/her supervisor
Skills
- Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience
- 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
- Experience in Post Market Surveillance activities is desirable
- Ability to interpret company policies and procedures to complete a variety of tasks
- 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
- Registered Nurse preferred
- Minimum 2-5 years of previous clinical work experience
- 2 or more years of experience in Post Market Surveillance, Medical Device Reporting and Product Vigilance monitoring is highly desirable
Benefits
- Remote workplace; home office location with potential hybrid option if residing within commuting distance (typically 75 miles/120km) of a Dexcom site
- Reasonable accommodations for individuals with disabilities as part of employment selection process
Company Overview
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