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
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
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
Prepare or review event narratives for internal review (e.g. RA)
or external review (e.g. CEC), as well as for regulatory
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
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
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
Preferred Qualifications: Internal medicine/cardiology/cardiac
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
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
Edwards is an Equal Opportunity/Affirmative Action employer
including protected Veterans and individuals with disabilities.