BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Full-timeOn-siteSenior
Mainz, München
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BI
BioNTech SEManager Safety Operations(m/w/x)
Mainz, München
Full-timeOn-siteExperienced
Description
You will drive patient safety by managing operational activities across clinical trials, from overseeing case reporting to ensuring all global regulatory deliverables meet high standards.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Advanced degree in life sciences, pharmacy, public health, or related field
- •Minimum 3 years of clinical research and pharmacovigilance experience
- •2 years of case processing experience
- •Post-marketing experience is a plus
- •Strong knowledge of GCP, GVP, and regulatory requirements
- •Strong scientific writing, project management, and collaboration skills
- •Fluency in English (written and spoken)
Education
Master's degree
OR
Doctoral / PhD
Work Experience
3 years
Tasks
- •Manage safety operational setup and close-out
- •Develop trial-specific plans and data transfer strategies
- •Review safety documents and management plans
- •Contribute to safety process improvements
- •Act as primary safety contact for trials
- •Oversee investigational medicinal product activities
- •Manage end-to-end individual case safety reports
- •Perform case triage and MedDRA coding
- •Conduct causality assessments and vendor oversight
- •Coordinate SUSAR reporting to regulatory authorities
- •Ensure compliance with global reporting timelines
- •Support safety physicians with medical data review
Tools & Technologies
GCPGVP
Languages
English – Business Fluent
Benefits
Competitive Pay
- •Competitive remuneration packages
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE 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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BioNTech SEManager Safety Operations(m/w/x)
Mainz, München
Full-timeOn-siteExperienced
New Job?Nejo!
The AI Job Search Engine
Description
You will drive patient safety by managing operational activities across clinical trials, from overseeing case reporting to ensuring all global regulatory deliverables meet high standards.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Advanced degree in life sciences, pharmacy, public health, or related field
- •Minimum 3 years of clinical research and pharmacovigilance experience
- •2 years of case processing experience
- •Post-marketing experience is a plus
- •Strong knowledge of GCP, GVP, and regulatory requirements
- •Strong scientific writing, project management, and collaboration skills
- •Fluency in English (written and spoken)
Education
Master's degree
OR
Doctoral / PhD
Work Experience
3 years
Tasks
- •Manage safety operational setup and close-out
- •Develop trial-specific plans and data transfer strategies
- •Review safety documents and management plans
- •Contribute to safety process improvements
- •Act as primary safety contact for trials
- •Oversee investigational medicinal product activities
- •Manage end-to-end individual case safety reports
- •Perform case triage and MedDRA coding
- •Conduct causality assessments and vendor oversight
- •Coordinate SUSAR reporting to regulatory authorities
- •Ensure compliance with global reporting timelines
- •Support safety physicians with medical data review
Tools & Technologies
GCPGVP
Languages
English – Business Fluent
Benefits
Competitive Pay
- •Competitive remuneration packages
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE 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
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
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