Sobi
Global Product Safety Science Lead(m/w/x)
Full-timeRemoteSenior
München
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EDEdwards Lifesciences
Senior Clinical Safety Specialist(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Tracking and processing complex adverse device events from clinical trial sites for medical device innovations. Strong medical background with cardiology experience essential. Flexible working hours, meal benefits.
Requirements
- Bachelor's Degree in related field
- Strong medical background, cardiology experience, and interest in clinical trial safety
- Experience in medical device, healthcare, or related environment
- Business level English (written and spoken)
- Proven expertise in MS Office Suite
- Excellent written and verbal communication skills
- Demonstrated problem-solving and critical thinking skills
- Knowledge of Edwards policies and quality compliance
- Proficient knowledge of medical terms and human anatomy
- Full knowledge of Medical Device Reporting regulations
- Good knowledge of Good Documentation Practices (GDP)
- 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
- Ability to work in a team environment
- Ability to interact with senior personnel on significant matters
- Adhere to all company rules and requirements
Tasks
- Track and process complex adverse device events from clinical trial sites
- Collect source documents for key adverse events from clinical trial sites
- Determine regulatory reporting requirements based on event criteria and causality
- Interact with study committees for safety data collection and reconciliation
- Prepare safety event reports for clinical, regulatory, and complaint handling submissions
- Ensure compliance with worldwide reporting requirements, including expedited case reports
- Understand corporate and global regulations, guidelines, and writing practices
- Coach and mentor junior clinical safety specialists
- Handle and review adverse events according to SOP and regulatory requirements
- Identify problems and lead projects to improve processes and procedures
Work Experience
- approx. 4 - 6 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office Suite
Benefits
Flexible Working
- Flexible working hours
- Remote working
Retirement Plans
- Pension plan
Other Benefits
- Risk insurance
- Service awards
Free or Subsidized Food
- Meal benefits
More Vacation Days
- Enhanced leave benefits
Parking & Commuter Benefits
- Transportation benefits
Competitive Pay
- Employee stock purchase programme
Mental Health Support
- Employee assistance programme
Healthcare & Fitness
- Comprehensive wellness programme
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Edwards Lifesciences and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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EDEdwards Lifesciences
Senior Clinical Safety Specialist(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Tracking and processing complex adverse device events from clinical trial sites for medical device innovations. Strong medical background with cardiology experience essential. Flexible working hours, meal benefits.
Requirements
- Bachelor's Degree in related field
- Strong medical background, cardiology experience, and interest in clinical trial safety
- Experience in medical device, healthcare, or related environment
- Business level English (written and spoken)
- Proven expertise in MS Office Suite
- Excellent written and verbal communication skills
- Demonstrated problem-solving and critical thinking skills
- Knowledge of Edwards policies and quality compliance
- Proficient knowledge of medical terms and human anatomy
- Full knowledge of Medical Device Reporting regulations
- Good knowledge of Good Documentation Practices (GDP)
- 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
- Ability to work in a team environment
- Ability to interact with senior personnel on significant matters
- Adhere to all company rules and requirements
Tasks
- Track and process complex adverse device events from clinical trial sites
- Collect source documents for key adverse events from clinical trial sites
- Determine regulatory reporting requirements based on event criteria and causality
- Interact with study committees for safety data collection and reconciliation
- Prepare safety event reports for clinical, regulatory, and complaint handling submissions
- Ensure compliance with worldwide reporting requirements, including expedited case reports
- Understand corporate and global regulations, guidelines, and writing practices
- Coach and mentor junior clinical safety specialists
- Handle and review adverse events according to SOP and regulatory requirements
- Identify problems and lead projects to improve processes and procedures
Work Experience
- approx. 4 - 6 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office Suite
Benefits
Flexible Working
- Flexible working hours
- Remote working
Retirement Plans
- Pension plan
Other Benefits
- Risk insurance
- Service awards
Free or Subsidized Food
- Meal benefits
More Vacation Days
- Enhanced leave benefits
Parking & Commuter Benefits
- Transportation benefits
Competitive Pay
- Employee stock purchase programme
Mental Health Support
- Employee assistance programme
Healthcare & Fitness
- Comprehensive wellness programme
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Edwards Lifesciences and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Edwards Lifesciences
Industry
Healthcare
Description
The company is a global leader in patient-focused medical innovations, offering opportunities in a dynamic work environment.
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