Manager, Medical Safety Officer
Company: Edwards Lifesciences
Posted on: August 15, 2019
This is a unique opportunity to join the Global Clinical Safety
group of an early-stage medical device team, Transcatheter Mitral
and Tricuspid Therapies (TMTT), focused on developing solutions for
patients suffering from structural heart disease. The individual
will join a fast paced, dynamic team playing a pivotal role in the
safety oversight of Edwards Lifesciences sponsored clinical
studies, in a business unit that is bringing new medical devices
from concept to commercialization.As the Medical Safety Officer
(MSO), you 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.Job
- Provide medical safety oversight for multiple clinical
- Serve as medical safety SME to the cross-functional teams,
including clinical trial management, clinical development,
regulatory & medical affairs, and R&D.
- Conduct comprehensive assessment of adverse events and device
- Interact with site coordinators and trial managers for the
purposes of safety data collection and data reconciliation, when
- Communicate with site investigators, as needed, to discuss
complex adverse events.
- Report adverse events and complaints according to regulatory
requirements, trial safety processes and Edwards' procedures.
- Respond to safety queries from regulatory authorities.
- Prepare presentations for DSMB. Attend/present at Open Session
of DSMB meetings.
- Review and quality assurance of CEC packets and adjudication
- Provide safety and medical expertise to Quality
Compliance/Complaint Handling on medical aspects of reported
- Prepare or review complex event narratives for internal use
(e.g. medical affairs, quality, RA) or external review (Clinical
Endpoints Committee), as well as for regulatory submissions.
- Review and analyze aggregate safety data to identify early
safety signals and escalate to leadership, with recommended next
- Develop training materials and train Edwards and site personnel
on compliant safety reporting and appropriate support
- Collaborate on clinical risk/benefit analysis documents to meet
internal and regulatory requirements.
- Provide input on clinical trial protocols, safety endpoints and
definitions, and develop safety sections of study protocols.
- Review and provide input to regulatory and clinical reports and
- Represent safety in cross-functional and core team
- Represent safety in internal and external audits
- An MD (or equivalent medical degree) is required.
- 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.
- 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
Keywords: Edwards Lifesciences, Irvine , Manager, Medical Safety Officer, Healthcare , Irvine, California
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