Senior Specialist, Clinical Safety (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 expand 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 is our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.As a Senior Specialist, Clinical Safety in the THV business unit, you will assure adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with EW procedures and ethical standards to ensure patient safety in clinical trials.How you'll make an impact:
Provide oversight on all safety processes from the site to the CEC to ensure process flow is managed efficiently and effectively
Develop training programs and metrics for safety team knowledge in collaboration with management to optimize the application of knowledge and performance
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 medical narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate safety officers review and CEC review in accordance to regulatory requirements, trial safety processes, and EW procedures
Educate and provide training to enrolling sites to ensure protocol requirements are followed
Provide guidance and direction to ancillary staff
Collaborate with clinical safety team members and other functional groups
Other incidental duties
What you'll need (Required):
Master's Degree in Biological Studies, Life Sciences Studies or MSN Plus 3 years of previous hands-on clinical research related experience Required or
Bachelor's Degree in Biological Studies, Life Sciences Studies or Nursing degree Plus 5 years of previous hands-on clinical research related experience Required
What else we look for (Preferred):
Experience with an ERP software, CTMS (Clinical Trial Management System) and Patient Tracking system
Full understanding of medical terminology as it relates to clinical safety
Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system preferred
Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)
Excellent written and verbal communication skills and interpersonal relationship skills with ability to manage confidential information with discretion
Demonstrated problem-solving and critical thinking skills
Ability to manage competing priorities in a fast fast-paced environment with strict attention to detail
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 professionally with senior internal and external personnel on significant matters often requiring coordination between organizations
Ability to understand policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
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 $108,000 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 RequirementEdwards 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.