Rep, Clinical Safety in Garching bei München bei Edwards Lifesciences

Edwards Lifesciences

Review information on adverse events to allow for continuous monitoring of patient safety data in clinical trials in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with EW procedures and ethical standards.

Key Responsibilities:

• Prepare packets from source documents and submit packets for event adjudication to CEC (Clinical Event Committee), IMR (Independent Medical Reviewer) or internal review
• Review adverse event notifications and case report forms received from the investigational sites in the electronic database to support Safety Officers in daily safety review. Prepare adverse event and/or complaint review forms for Safety review. Report complaints from clinical studies to Complaint Handling incorporating information from multiple sources, in accordance with regulatory requirements, trial safety processes and Edwards procedures
• Reconcile data and maintain/update in-house safety tracking systems for sponsor’s review, complaint reporting, source documents collection, and adjudication process
• Request source documents from study sites for event adjudication
• Compile and audit patient safety files for correctness and completeness to ensure all necessary clinical information and documentation in place as required by regulations, trial safety processes, and Edwards procedures
• Other incidental duties

Associate's Degree or equivalent 2 years experience Previous related working in clinical studies Required
Bachelor's Degree Preferred

Additional Skills:

• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Substantial knowledge and understanding of Edwards policies and procedures relevant to clinical study documentation
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)
• Good written and verbal communications skills
• Good problem-solving skills
• 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 inter-departmental teams
• Ability to provide feedback in a professional, direct, and tactful manner
• 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

What is it like to work at Edwards Lifesciences in Germany?
As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.
We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).
Edwards Lifesciences in Germany also offers the following benefits:
Competitive Compensation and Benefits package
Flexible working hours, remote working
Pension plan Risk
Insurance Meal Benefits
Service Awards Enhanced
Leave Benefits
Transportation Benefits
Employee Stock Purchase Programme
Employee Assistance Programme
Comprehensive Wellness Programme including onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities and much more.

Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.

About Edwards Lifesciences

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,