The Sr. Manager of Clinical Customer Advocacy is part of the Quality team, working closely with the Quality and Medical Affairs organizations. The Sr. Manager of Clinical Customer Advocacy plays a pivotal role in evaluating customer/user risk and in assessing the real or potential impact of product performance issues on patient safety. The reactive elements of the role (addressing quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities which should be taken to minimize potential risk to patients, both on current as products and products in development.
Essential Duties and Responsibilities:
- Participate in risk management activities, including system hazard analysis (SHA) and design failure modes and effects analysis (DFMEA) for new product development
- Participate in post market activities, assessing product risk-benefit and provide medical input/review to Risk Management Reports, CAPA evaluations and Health Hazards Evaluations
- Provide input on responses to AEs, 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. The position will review post-marketing safety data, individual case safety reports, and literature reports with possible safety data and will aggregate complaint data. In conjunction with the VP of Medical Affairs or a medical director, the position will advise on failure investigations and provide medical opinion when deciding on reportability.
- The position will work with the Customer Advocacy team to ensure that telephone scripts are appropriately worded to obtain pertinent safety information and that appropriate analytics are used to assess the complaint data.
- Review and provide input on any complaints regarding serious adverse events or death. Contact medical professionals for additional information as required.
- Participate or lead discussion with the compliance arms of regulatory agencies
- Maintain a state of inspection readiness.
- Manage Clinical Customer Advocacy Specialists
Must be self-motivated, self-confident, and be able to work independently. However, team work is also essential as the position will collaborate closely with Dexcom sales, marketing, business development, and clinical affairs teams.
Education and Experience Requirements:
- Medical degree (MD or RN) is required
- 5 - 8years of previous management or lead experience
- 13+ years of industry experiencerequired
- Knowledge of and experience in the field of diabetes and CGM technology is desirable.
- 2 or more years of experience in Medical Device Reporting and Product Vigilance monitoring or reporting or a leadership position on risk management committee(s) is highly desirable.
- Less than 20% of the time; occasional international travel may be required.