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Manager, Medical Safety Officer

Company: Edwards Lifesciences
Location: Irvine
Posted on: August 15, 2019

Job Description:

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 Functions:


  • 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 comprehensive assessment of adverse events and device deficiencies.
  • Interact with site coordinators and trial managers for the purposes of safety data collection and data reconciliation, when required.
  • 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 results.
  • Provide safety and medical expertise to Quality Compliance/Complaint Handling on medical aspects of reported complaints.
  • 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 steps.
  • Develop training materials and train Edwards and site personnel on compliant safety reporting and appropriate support documentation.
  • 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 submissions.
  • Represent safety in cross-functional and core team meetings.
  • Represent safety in internal and external audits

    #LI-MO1
    #MI

    Required Education/Skills/Experience:


    • 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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