Edwards has an exciting opportunity in the Transcatheter Mitral and Tricuspid Technologies (TMTT) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.
As the Associate Manager, Clinical Safety you will ensure patient safety in clinical trials by conducting safety assessments, identifying/analyzing safety signals and trends, creating and implementing safety processes and trainings and providing clinical safety expertise.
- Conduct Sponsor assessment of adverse events/serious adverse events from clinical studies, including UADE (Unanticipated Adverse Device Effect) determinations, assessment of seriousness, device and procedure relationship and report adverse events according to regulatory requirements, trial safety processes and Edwards’ procedures.
- Prepare or review event narratives for internal review or external review (Clinical Endpoints Committee), as well as for regulatory submissions.
- Determine whether or not an event requires formal review (CEC adjudication).
- Review and analyze aggregate safety reports to identify early safety signals and escalate to leadership with recommended next steps.
- Evaluate the need for a change in the clinical risk/benefit analysis.
- Advise Complaint Handling on medical aspects of reported complaint information.
- Train and advise Edwards and site personnel on safety reporting and appropriate support documentation.
- Contribute to safety aspects of protocol design; regulatory submissions, reports, clinical summaries, updates and other
- Participate as a member of the cross-functional team and provide safety input to risk management documents and other cross functional documents , as needed
- An MD (or equivalent medical degree) is required. At least 3 years of industry experience with device/drug safety or more than 3 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.
- Substantial computer literacy.
- Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
- 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
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
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