Senior Clinical Safety Specialist job opportunity at Edwards Lifesciences Corporation.

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DateMore Than 30 Days Ago bot
Edwards Lifesciences Corporation Senior Clinical Safety Specialist
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Pattern: full-time
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loacation Germany-Garching, Germany
loacation Germany-Garchi..........Germany

The Edwards Transcatheter Aortic Heart Valves unit (THV) consists of our SAPIEN family of transcatheter aortic and pulmonic heart valves which are the most widely prescribed transcatheter heart valves in the world! Edwards leadership in transcatheter heart valve replacement includes a commitment to meaningful innovation, rigorous scientific study, extensive clinician training and education, and significant investment in new applications of the technology. The Edwards SAPIEN valve platform continues to raise the bar as the most widely studied transcatheter heart valve worldwide. We have an opportunity to join our Clinical Safety Team in Munich Germany, on an 18-month contract. As either an experienced Medical Device or Drug Safety Specialist OR a Medical Professional with an active interest in clinical trial safety and cardiology, the successful candidate will be the Clinical Safety contact for European Clinical Trials. This position has responsibility for meeting all reporting and recording requirements of Safety Data (Adverse Events) per current industry regulations. This role is to cover maternity leave on a fixed term contract of 18-months, starting March 2026. The role will be office based in Munich (some hybrid working may be considered). How you will make an impact: • Track and process complex and/or serious adverse device events (ADEs) from clinical trial sites. Collect 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. • Lead preparation of 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. • Understand applicable corporate and global regulations, guidelines, SOPs and writing practices. • May coach and mentor junior level clinical safety specialists • Responsible for Adverse Event handling and reviewing according to SOP and European and FDA regulatory requirements. • Identify problems and lead projects to improve processes, procedures, and/or practices; recommend and resolve solutions, including devising new approaches to problems encountered • Other incidental duties What you will need: Bachelor's Degree in as a minimum in related field, in addition to strong previous relevant Clinical trial and medical device and/or drug safety experience. Alternatively we would consider someone with a strong medical background, cardiology experience and an interest in clinical trial safety. Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment Business level English (written and spoken ) is required. What else we look for: • Proven expertise in MS Office Suite and ability to operate general office machinery • Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills • Demonstrated problem-solving, critical thinking, and investigative skills • Substantial knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance • Proficient 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 key contact representing the department on projects • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations • Adhere to all company rules and requirements 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. 

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