About this role
Role Overview
- 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.
- 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.
- 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.
- Contribute to 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.
Requirements
- 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.
- 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.
- Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience.
Benefits
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.