Clinical Safety Officer

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 Clinical Safety Officer

• Transcatheter Heart Valve will assure 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.

• Analyze medical records received from enrolling sites to identify AEs (Adverse Events), SAEs (Serious Adverse Events) or UADEs (Unanticipated Adverse Device Effects) to confirm protocol definition and propose recommendations to site.

• Develop and write complex medical narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate safety officers and CEC review in accordance to regulatory requirements, trial safety processes, and EW procedures.

• Provide oversight on all safety processes from the site to the CEC to ensure process flow is managed efficiently and effectively.

• Educate and provide training to enrolling sites to ensure protocol requirements are followed.

• Develop training programs and metrics for safety team knowledge in collaboration with management to optimize application of knowledge and performance.

What you'll need (Required):

• Bachelor's Degree or equivalent in biological or Lifesciences field or Nursing degree

• 5 years' experience previous hands-on clinical research related.

• Experience with an ERP software, CTMS (Clinical Trial Management System) and Patient Tracking system

• OR-

• Master's Degree or equivalent in Related field

What else we look for (Preferred):

• Medical Device Industry

• BSN degree or MSN degree

• Strong cardiovascular experience (preferably in TAVR)

• Clinical Trials experience

• International and domestic medical device regulatory guidelines relevant to clinical studies.

• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)

• Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system.

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

• Excellent written and verbal communication skills and interpersonal relationship skills

• Demonstrated problem-solving and critical thinking skills.

• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.

• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

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 $103,000 to $146,000 (highly experienced).

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

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.