Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact by:

The Manager, Clinical Safety Officer - Transcatheter Heart Valve, will ensure adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with Edwards Lifesciences procedures and ethical standards to ensure patient safety in clinical trials. Provide mentoring and guidance to team members. This is a subject matter expert, individual contributor position.

• Assess adverse events with high complexity utilizing clinical background and safety experience to provide on-going assessment of EW products for long term performance in accordance with internal safety work instructions and adherence to the quality review process.

• Compose medical narratives in accordance to THV Clinical Safety Process and regulatory requirements.

• Provide guidance and review narratives from team members and external vendors (e.g., CEC) to ensure quality on content.

• Design training programs related to safety surveillance of the study and provide education to the sites in reporting adverse events according to the protocol and CEC Charter definitions.

• Provide direction to team members to improve processes within the department and delegate tasks to Safety team members for department projects and ensure team deliverables are met within the required timeline.

• Develop and/or update work instructions and SOPs to ensure CEC and DSMB charters are in accordance.

• Act as a liaison between THV Clinical Monitoring department and study sites regarding Safety-related matters.

• Provide on-site assessment and resolution of safety related issues which include completing document assessment and retrieval for adverse event review pending regulatory submission deadlines.

• Provide site training and/or retraining and perform on-site review of safety events when necessary.

What you'll need (Required):

• Bachelor's Degree in in biological or Lifesciences field , 8 years’ experience of previous hands-on clinical research and experience in an acute cardiovascular or critical care setting.

What else we look for (Preferred):

• M.D., Doctor of Medicine.

• Extensive understanding of medical terminology as it relates to clinical safety.

• Extensive understanding of pre-clinical testing protocols, hospital environments and sterile techniques.

• Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification).

• Medical Coding Experience (Maddra).

• Proven successful project management skills.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $115,000 to $163,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will accepted while this position is posted on our Career website.