Specialist, Clinical Safety

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 committees (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 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 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.