This position has been posted in anticipation for future openings within Medical Safety -Devices. We anticipate hiring Medical Safety Officers at varying experience levels. If you meet the minimum job requirements, you will receive additional information about our Clinical Affairs Talent Community.
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. We will anticipated needing talent who are manager levels as well as subject matter experts (SMEs). The MSO will work in close collaboration with cross-functional teams, including clinical trial management, clinical development, regulatory & medical affairs, and R&D.
Provide medical safety oversight for multiple clinical studies.
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
Minimum Required Experience:
An MD, DO (or equivalent medical degree)
At least 5 years of medical/clinical or industry experience with device/drug safety
At least 5 years of clinical research experience and safety reporting
Must have at least 3 years experience working as a Medical Safety Officer in Class III device studies
In addition to meeting minimum requirements, it would be nice to have the following:
Internal medicine/cardiology/cardiac surgery preferred
Class III Medical Device experience preferred
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences Corp