Manager, Medical Safety Officer

$130,000 - $170,000/Yr

Edwards Lifesciences - Oklahoma City, OK

Full-time - Mid Level

Oklahoma City, OK

Miscellaneous Manufacturing

About the position

The Manager, Medical Safety Officer for the Transcatheter Heart Valve (THV) business unit plays a crucial role in ensuring patient safety by conducting assessments of adverse events and device deficiencies reported through clinical studies. This position involves collaboration with clinical teams and regulatory bodies to enhance patient care and support the development of innovative cardiovascular solutions.

Responsibilities

• Conduct medical Sponsor assessment of adverse events and device deficiencies reported through clinical studies.
• Determine what additional information is required for comprehensive assessment and adjudication.
• Interact with site coordinators and trial managers for safety data collection and data reconciliation.
• Report adverse events and complaints according to regulatory requirements and trial safety processes.
• Collaborate with safety management to create CEC and DSMB/DMC charters.
• Determine which individual events require adjudication based on charters.
• Prepare or review event narratives for internal and external review, including regulatory submissions.
• Provide input into safety sections of study protocols and clinical/regulatory reports.
• Train and advise Edwards and site personnel on compliant safety reporting.
• Provide medical guidance to Quality Compliance/Complaint Handling on reported complaint information.
• Collaborate with senior safety management to analyze aggregate safety reports for early safety signals.
• Represent safety in cross-functional and core team meetings.

Requirements

• Physician Assistant (PA) with a Master's degree in Physician Assistant Studies (MPAS), Health Science (MHS), or Medical Science (MMSc) plus 5 years of combined medical/clinical and relevant industry experience.
• Nurse Practitioner (NP) with a Master's of Science in Nursing (MSN) or advanced practice registered nurse (APRN) or equivalent plus 5 years of combined medical/clinical and relevant industry experience.
• M.D, DO or equivalent plus 2 years of relevant medical/clinical and relevant industry experience.

Nice-to-haves

• Experience in internal medicine/cardiology/cardiac surgery strongly preferred.
• Experience with Medical Device strongly preferred.
• Excellent written and verbal communication skills and interpersonal relationship skills.
• Ability to translate complex and technical information to project team management and key leadership.
• Extensive knowledge of medical safety monitoring principles and concepts.
• Expert knowledge in anatomy, pathology, and physiology.
• Expert understanding of regulatory requirements and adverse events reporting.
• Knowledge of Edwards Environmental Health and Safety and Quality guidelines.
• Demonstrates strict attention to detail and the ability to influence change.
• Ability to manage competing priorities in a fast-paced environment.
• Must be able to work in a team environment with frequent inter-organizational interactions.

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs to address diverse individual needs