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 Medical 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.

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.

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 internal medicine/cardiology/cardiac surgery

• 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