Edwards Lifesciences Clinical Safety Specialist, Transcatheter Mitral & Tricuspid Therapies (Germany) in Unterschleissheim, Germany
Primary Clinical Safety contact for European Edwards-Trials. Responsible for meeting all reporting and recording requirements of Safety Data (Adverse Events) per current regulations.
Key Responsibilities: • Track and process adverse device events (ADEs) from clinical trial sites. Review source documents on all key adverse events from clinical trial sites. Determine regulatory reporting requirements based on serious criteria, causality and whether event is anticipated per clinical protocol/IB. • Interact with study commitees (i.e. CEC) for the purposes of safety data collection, data reconciliation, and providing source documents for the CEC reviews. • Prepare safety event reports for clinical, regulatory and complaint handling submission in compliance with worldwide reporting requirements including individual expedited case reports such as USADE, including aggregate reports and other regulatory documents as requested. • Identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered • Responsible for Adverse Event handling and reviewing according to SOP and European and FDA regulatory requirements. • Understand applicable corporate and global regulations, guidelines, SOPs and writing practices • Other incidental duties
Education and Experience: Bachelor's Degree or equivalent in as a minimum in related field , 3 years years experience of previous relevant Clinical experience required including safety experience Required and Other: Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment Required
Additional Skills: • Proven expertise in MS Office Suite and ability to operate general office machinery • Excellent written and verbal communication skills and interpersonal relationship skills • Demonstrated problem-solving, critical thinking, and investigative skills • Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance • Good knowledge of medical terms and human anatomy • Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations • Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing • Ability to manage confidential information with discretion • 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 inter-departmental teams and representing the department on specific projects • Ability to build productive internal/external working relationships • Adhere to all EHS rules and requirements 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
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 13,000 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.