Director, Medical 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.

This role can be either an onsite or hybrid role based at Edwards' Irvine campus, or a remote-based role in the U.S.

How you will make an impact:

The Director of Medical Safety Officer - Advanced Technology (AT) will develop a new safety division in the Advanced Technology business unit. An expert to provide technical expertise on safety assessments of adverse events and assure all events are reviewed and reported correctly. Identify patient and device safety issues for medical devices.

• Analyze and conduct Sponsor assessment of adverse events and device deficiencies with the highest complexity reported through clinical studies (e.g. assessment of seriousness, relationship to device and procedure, and UADE (Unanticipated Adverse Device Effect) determinations). Determine what additional information is required for comprehensive assessment and adjudication, when required. Interact with site coordinators and trial managers for the purposes of safety data collection and data reconciliation.

• Design CEC and DSMB/DMC charters, provide training to CEC and DSMB/DMC staff and physicians, and provide oversight of the overall process, including quality assurance of adjudication results and output.

• Report complex adverse events and complaints according to regulatory requirements, trial safety processes and Edwards' procedures. Respond to complex questions from regulatory authorities.

• Review and analyze aggregate safety reports to identify early safety signals on complex safety issues and escalate to leadership with recommended next steps.

• Represent safety in internal and external audits. Represent safety in cross-functional and core team meetings.

• Develop and lead the implementation of safety processes according to applicable regulatory requirements.

• Create or review and approve complex event narratives for internal review (e.g. R&D, quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions.

• Develop training materials and train Edwards and site personnel and safety committees on safety reporting and appropriate support documentation.

• Create and provide oversight to complex clinical risk/benefit analysis documents to meet internal and regulatory requirements.

• Provide input on clinical trial design and develop safety sections of study protocols, regulatory submissions, and clinical/regulatory reports.

• Travel up to 25%

? What you will need (Required):

• M.D, DO, Ph.D. or equivalent, 8 years' experience of relevant medical/clinical and relevant industry experience.

• Physician Assistant (PA) with a Master's degree in Physician Assistant Studies (MPAS), Health Science (MHS), or Medical Science (MMSc) or Nurse Practitioner (NP) with a Master's of Science in Nursing (MSN) or advanced practice registered nurse (APRN) or equivalent, 11 years' experience of combined medical/clinical and relevant industry experience.

What else we look for (Preferred):

• Experience in interventional cardiology/cardiovascular/cardiac surgery

• Safety Experience (US and European)

• Experience with Class III Medical Device

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with KOLs and clinical personnel.

• Ability to translate complex and technical information to project team management and key leadership.

• Recognized as an expert in own area within the organization while applying advanced technical principles, theories, and concepts in related disciplines.

• Expert knowledge of cardiovascular anatomy, pathology, and physiology

• Expert understanding of medical device regulatory requirements, related documents, and reports.

• Extensive knowledge of global adverse events reporting

• In-depth understanding of corporate/global procedures, standard operating procedures, and writing practices.

• Medical liaison with external physicians and clinicians

• Provides expert medical input to help provide solutions to difficult technical issues and help drive organizational projects.

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 $166,000 to $235,000 (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.

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

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.