Manager, Medical Safety Officer - Edwards Lifesciences
Lincoln, NE
About the Job
Manager, Medical Safety Officer - Transcatheter Heart Valve (THV)
Patients are at the heart of everything we do. As part of our Clinical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. 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.
As the Manager, Medical Safety Officer within our THV business unit, you will play a pivotal role by sharing your medical/ technical expertise on safety assessments of adverse events.
How you'll make an impact:
+ Conduct medical Sponsor assessment of adverse events and device deficiencies 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.
+ Report adverse events and complaints according to regulatory requirements, trial safety processes and Edwards’ procedures.
+ Collaborate with safety management to create CEC and DSMB/DMC charters.
+ Determine what individual events require adjudication based on charters.
+ Prepare or review event narratives for internal review (e.g. R&D, quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions.
+ Provide input into safety sections of study protocols, regulatory submissions, and clinical/regulatory reports, including clinical risk/benefit analysis as required
+ Train and advise Edwards and site personnel on compliant safety reporting and appropriate support documentation.
+ Provide medical guidance to Quality Compliance/ Complaint Handling on medical aspects of reported complaint information.
+ Collaborate with senior safety management to review and analyze aggregate safety reports to identify early safety signals
+ Represent safety in cross-functional and core team meetings
+ Other incidental duties
What you'll need (Required):
+ 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 Required Or
+ 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 Required Or
+ M.D, DO or equivalent Plus 2 years of relevant medical/clinical and relevant industry experience Required
What else we look for (Preferred):
+ 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 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
+ Extensive knowledge and understanding of principles, theories, and concepts relevant to medical safety monitoring
+ Expert knowledge in anatomy, pathology and physiology
+ Expert understanding of principles of regulatory requirements and adverse events reporting
+ Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines
+ Demonstrates strict attention to detail and the ability to influence change
+ Demonstrates ability to interact professionally with all organizational levels
+ Demonstrates ability to manage competing priorities in a fast-paced environment
+ Must be able to work in a team environment; frequent inter-organizational interactions including R&D, Quality, RA, etc.
+ Must be able to interact with external physicians and clinicians
+ Provides expert medical input to help provide solutions to difficult technical issues associated with specific organizational projects
+ Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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 $130,000 to $170,000 (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 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.
Patients are at the heart of everything we do. As part of our Clinical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. 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.
As the Manager, Medical Safety Officer within our THV business unit, you will play a pivotal role by sharing your medical/ technical expertise on safety assessments of adverse events.
How you'll make an impact:
+ Conduct medical Sponsor assessment of adverse events and device deficiencies 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.
+ Report adverse events and complaints according to regulatory requirements, trial safety processes and Edwards’ procedures.
+ Collaborate with safety management to create CEC and DSMB/DMC charters.
+ Determine what individual events require adjudication based on charters.
+ Prepare or review event narratives for internal review (e.g. R&D, quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions.
+ Provide input into safety sections of study protocols, regulatory submissions, and clinical/regulatory reports, including clinical risk/benefit analysis as required
+ Train and advise Edwards and site personnel on compliant safety reporting and appropriate support documentation.
+ Provide medical guidance to Quality Compliance/ Complaint Handling on medical aspects of reported complaint information.
+ Collaborate with senior safety management to review and analyze aggregate safety reports to identify early safety signals
+ Represent safety in cross-functional and core team meetings
+ Other incidental duties
What you'll need (Required):
+ 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 Required Or
+ 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 Required Or
+ M.D, DO or equivalent Plus 2 years of relevant medical/clinical and relevant industry experience Required
What else we look for (Preferred):
+ 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 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
+ Extensive knowledge and understanding of principles, theories, and concepts relevant to medical safety monitoring
+ Expert knowledge in anatomy, pathology and physiology
+ Expert understanding of principles of regulatory requirements and adverse events reporting
+ Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines
+ Demonstrates strict attention to detail and the ability to influence change
+ Demonstrates ability to interact professionally with all organizational levels
+ Demonstrates ability to manage competing priorities in a fast-paced environment
+ Must be able to work in a team environment; frequent inter-organizational interactions including R&D, Quality, RA, etc.
+ Must be able to interact with external physicians and clinicians
+ Provides expert medical input to help provide solutions to difficult technical issues associated with specific organizational projects
+ Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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 $130,000 to $170,000 (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 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.
Source : Edwards Lifesciences