+ Provide technical expertise on safety assessments of adverse events
+ Conduct medical Sponsor assessment of adverse events and device deficiencies reported through clinical studies (e.g. assessment of seriousness, relationship to device and procedure, and UADE (Unanticipated Adverse Device Effect) determinations). Determine what additional information is required for comprehensive assessment and adjudication, when required. Interact with site coordinators and trial managers for the purposes of safety data collection and data reconciliation.
+ Report adverse events and complaints according to regulatory requirements, trial safety processes and Edwards’ procedures.
+ Collaborate with safety management to create CEC and DSMB/DMC charters. Determine what individual events requires adjudication based on charters.
+ Prepare or review event narratives for internal review (e.g. R&D, quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions.
+ Provide input into safety sections of study protocols, regulatory submissions, and clinical/regulatory reports, including clinical risk/benefit analysis as required
+ Train and advise Edwards and site personnel on compliant safety reporting and appropriate support documentation.
+ Provide medical guidance to Quality Compliance/ Complaint Handling on medical aspects of reported complaint information.
+ Collaborate with senior safety management to review and analyze aggregate safety reports to identify early safety signals
+ Represent safety in cross-functional and core team meetings
+ Other incidental duties
+ Physician Assistant (PA) with a Master’s degree in Physician Assistant Studies (MPAS), Health Science (MHS), or Medical Science (MMSc) or Nurse Practitioner (NP) with a Master’s of Science in Nursing (MSN) or advanced practice registered nurse (APRN) or equivalent with 5 years of combined medical/clinical and relevant industry experience.
+ or M.D, DO or equivalent with 2 years of relevant medical/clinical and relevant industry experience.
+ Experience in internal medicine/cardiology/cardiac surgery is a plus.
+ Experience with Medical Device is a plus.
+ Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with KOLs and clinical personnel
+ Ability to translate complex and technical information to project team management and key leadership
+ Extensive knowledge and understanding of principles, theories, and concepts relevant to medical safety monitoring
+ Expert knowledge in anatomy, pathology and physiology
+ Expert understanding of principles of regulatory requirements and adverse events reporting
+ Ability to influence change
+ Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast paced environment
+ Must be able to work in a team environment; frequent inter-organizational interactions including R&D, Quality, RA, etc.
+ Must be able to interact with external physicians and clinicians
+ Provides expert medical input to help provide solutions to difficult technical issues associated with specific organizational projects
+ Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.
Title: Medical Safety Manager, Transcatheter Mitral and Tricuspid Therapies
Location: Europe, Middle East, Africa, Canada (EMEAC)-Germany
Job Number: 019197