Edwards has an exciting opportunity in the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.
As the Specialist, Clinical Safety, you will assure adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with Edwards’ 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
Evaluate packets (compiled by lower level employees) from source documents to ensure accuracy for event adjudication to CEC (Clinical Event Committee)
Develop and write 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
Bachelor's degree in biological or Lifesciences field required.
Nursing background with focus on CVICU, Cardiac Cath Lab, Cardiovascular or Cardiac specialties strongly preferred.
Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred
8 years of previous hands-on clinical research and experience in an acute cardiovascular or critical care setting required
Proven successful project management skills
Proven expertise in MS Office Suite, Adobe, ERP software (e.g. JDE), CTMS (Clinical Trial Management System) and Patient Tracking system; ability to operate general office machinery
Excellent written and verbal communication skills and interpersonal relationship Extensive knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
skills including consultative and relationship management skills
Demonstrated problem-solving and critical thinking skills
Extensive understanding of pre-clinical testing protocols, hospital environments and sterile techniques
Extensive understanding of medical terminology as it relates to clinical safety
Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including serving as consultant to management.
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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, Californi...a, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.