Edwards has a unique opportunity for a Manager, Medical Safety Officer in the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.
The Medical Safety Officer will be responsible for the medical safety oversight of multiple clinical trials, including identifying, analyzing, and escalating safety signals and trends. The MSO will also serve as a medical safety subject matter expert (SME) to the cross-functional teams, including clinical trial management, clinical development, regulatory & medical affairs, and R&D. This is a Subject Matter Expert role, Manager level, without direct reports.
This role is located in Irvine, CA.
Essential Job Functions / Key Responsibilities:
- Provide medical safety oversight for multiple clinical studies.
- Serve as medical safety SME to the cross-functional teams, including clinical trial management, clinical development, regulatory & medical affairs, and R&D.
- Conduct medical assessment of adverse events (AE) and device deficiencies reported in clinical trials.
- Report AE's and complaints according to regulatory requirements, trial safety processes and Edwards’ procedures.
- Review and analyze aggregate safety reports to identify early safety signals and escalate to leadership with recommended next steps.
- Provide medical guidance to Quality Compliance/ Complaint Handling on medical aspects of reported complaint information.
- Provide input on clinical trial protocols, safety endpoints and definitions, and develop safety sections of study protocols.
- Draft/Design CEC and DSMB/DMC charters and CEC forms, and provide oversight of internal and external CEC and DSMB/DMC process. Perform quality assurance of adjudication results and output.
- Prepare or review event narratives for internal review (e.g. RA) or external review (e.g. CEC), as well as for regulatory submissions.
- Collaborate on clinical risk/benefit analysis documents to meet internal and regulatory requirements.
- Develop training materials and train Edwards, site personnel and safety committees on compliant safety reporting and appropriate support documentation.
- Serve as a key stakeholder in the analysis and review of safety-related data in preparation of regulatory and clinical reports and submissions, podium presentations and manuscript development.
Minimum Requirements and Basic Qualifications:
- MD, DO (or equivalent OUS medical degree) with at least 5 years of industry experience with device/drug safety or more than 5 years of clinical research experience and safety reporting is required
- Internal medicine/cardiology/cardiac surgery preferred
- Class III Medical Device experience preferred
- Excellent written and verbal communication skills, presentation skills, interpersonal skills and analytical skills are a must.
- Ability to translate complex and technical information to project team management and key leadership
- Substantial computer literacy.
- Strict attention to detail.
- Strong understanding of cardiovascular anatomy, pathology and physiology
- Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
- Ability to communicate and relate well with key opinion leaders and clinical personnel
- Ability to manage competing priorities in a fast-paced environment
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.