BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Full-timeOn-siteSenior
Mainz, München
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BIBioNTech SE
(Senior-) Director Head of Medical Review (Pharmacovigilance)(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Leading a hybrid team of physicians in medical assessment of ICSRs, SUSARs, and immune-mediated events. 7-10 years pharmacovigilance experience in biotech/pharma required. Oncology expertise a plus, with Veeva Vault Safety proficiency.
Requirements
- Medical or advanced life sciences degree; PhD or post-graduate training in pharmacovigilance preferred
- 7–10 years pharmacovigilance experience in biotech or pharmaceutical industries; oncology expertise advantageous
- Leadership experience as Medical Review Lead or similar for Senior Director consideration
- Comprehensive knowledge of global pharmacovigilance regulations (ICH, GVP) and hands-on ICSR processing experience
- Proficiency in safety databases such as Veeva Vault Safety
- Strong communication skills with ability to convey complex concepts clearly
- Excellent English skills
Tasks
- Lead and mentor a hybrid team of medical review physicians
- Oversee high-quality medical assessments of ICSRs
- Focus on critical cases like SUSARs, immune-mediated events, and pDILI
- Drive continuous improvement in medical review processes
- Provide expert guidance on ICSR assessments
- Establish SOPs for consistent medical case reviews
- Collaborate with Global Clinical Development and Quality
- Manage vendor relationships and performance
- Ensure alignment with global regulatory standards
- Foster an environment of accountability and innovation
Work Experience
- 7 - 10 years
Education
- Bachelor's degree
Languages
- English – Native
Tools & Technologies
- Veeva Vault Safety
- ICH
- GVP
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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BIBioNTech SE
(Senior-) Director Head of Medical Review (Pharmacovigilance)(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Leading a hybrid team of physicians in medical assessment of ICSRs, SUSARs, and immune-mediated events. 7-10 years pharmacovigilance experience in biotech/pharma required. Oncology expertise a plus, with Veeva Vault Safety proficiency.
Requirements
- Medical or advanced life sciences degree; PhD or post-graduate training in pharmacovigilance preferred
- 7–10 years pharmacovigilance experience in biotech or pharmaceutical industries; oncology expertise advantageous
- Leadership experience as Medical Review Lead or similar for Senior Director consideration
- Comprehensive knowledge of global pharmacovigilance regulations (ICH, GVP) and hands-on ICSR processing experience
- Proficiency in safety databases such as Veeva Vault Safety
- Strong communication skills with ability to convey complex concepts clearly
- Excellent English skills
Tasks
- Lead and mentor a hybrid team of medical review physicians
- Oversee high-quality medical assessments of ICSRs
- Focus on critical cases like SUSARs, immune-mediated events, and pDILI
- Drive continuous improvement in medical review processes
- Provide expert guidance on ICSR assessments
- Establish SOPs for consistent medical case reviews
- Collaborate with Global Clinical Development and Quality
- Manage vendor relationships and performance
- Ensure alignment with global regulatory standards
- Foster an environment of accountability and innovation
Work Experience
- 7 - 10 years
Education
- Bachelor's degree
Languages
- English – Native
Tools & Technologies
- Veeva Vault Safety
- ICH
- GVP
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
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