Novartis
Global Program Safety Lead(m/w/x)
Full-timeOn-siteSenior
Basel
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NONovartis Pharma AG
Global Head Mechanistic Safety and Safety Signal Management(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Leading enterprise-wide mechanistic safety strategy and signal management for drug development at a global pharma company. Medical degree and extensive drug development experience required. Strategic leadership across global development teams.
Requirements
- Medical degree, strong clinical sciences and patient safety grounding
- Fluent English (spoken and written)
- Experience in clinical trials (phases 1, 2, 3)
- Extensive drug development experience (preclinical and clinical stages)
- Expertise in preparing or contributing to clinical and safety assessments and regulatory safety submissions
- Leadership in cross-functional, multicultural teams (matrix environment)
- Strong capability in managing complex safety issues
- Deep understanding of clinical trial methodology, regulatory expectations, scientific approaches, publication development
- Track record of peer-reviewed scientific publications
- Exceptional communication and stakeholder engagement skills
- Specialty Board Certification (Internal Medicine, Clinical Pharmacology and Toxicology, Gastroenterology, or Cardiology)
- Understanding of additional major language (German or French)
- Additional experience with statistical methods
- Cross Functional Teams
- Medical Strategy
- Process Safety Management
- Regulatory Compliance
- Safety Science
Tasks
- Lead enterprise-wide mechanistic safety strategy
- Anticipate, evaluate, and address emerging safety risks
- Chair the Medical Safety Review Board
- Guide rapid, scientifically sound safety decisions
- Provide expert leadership to development teams
- Strengthen safety insights from research to post-marketing
- Drive mechanistic investigation of safety signals
- Inform project progression and risk mitigation
- Oversee coordination of mechanistic activities
- Coordinate across development, research, and clinical functions
- Guide development and review of Risk Management Plans
- Guide development and review of safety mitigation strategies
- Evaluate safety findings from preclinical and clinical projects
- Foster collaboration with safety expert panels
- Ensure highest standards of scientific quality
- Lead and develop mechanistic safety associates
- Nurture expertise and scientific excellence
- Build impactful internal and external partnerships
- Advance innovative safety methodologies and best practices
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma AG 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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NONovartis Pharma AG
Global Head Mechanistic Safety and Safety Signal Management(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Leading enterprise-wide mechanistic safety strategy and signal management for drug development at a global pharma company. Medical degree and extensive drug development experience required. Strategic leadership across global development teams.
Requirements
- Medical degree, strong clinical sciences and patient safety grounding
- Fluent English (spoken and written)
- Experience in clinical trials (phases 1, 2, 3)
- Extensive drug development experience (preclinical and clinical stages)
- Expertise in preparing or contributing to clinical and safety assessments and regulatory safety submissions
- Leadership in cross-functional, multicultural teams (matrix environment)
- Strong capability in managing complex safety issues
- Deep understanding of clinical trial methodology, regulatory expectations, scientific approaches, publication development
- Track record of peer-reviewed scientific publications
- Exceptional communication and stakeholder engagement skills
- Specialty Board Certification (Internal Medicine, Clinical Pharmacology and Toxicology, Gastroenterology, or Cardiology)
- Understanding of additional major language (German or French)
- Additional experience with statistical methods
- Cross Functional Teams
- Medical Strategy
- Process Safety Management
- Regulatory Compliance
- Safety Science
Tasks
- Lead enterprise-wide mechanistic safety strategy
- Anticipate, evaluate, and address emerging safety risks
- Chair the Medical Safety Review Board
- Guide rapid, scientifically sound safety decisions
- Provide expert leadership to development teams
- Strengthen safety insights from research to post-marketing
- Drive mechanistic investigation of safety signals
- Inform project progression and risk mitigation
- Oversee coordination of mechanistic activities
- Coordinate across development, research, and clinical functions
- Guide development and review of Risk Management Plans
- Guide development and review of safety mitigation strategies
- Evaluate safety findings from preclinical and clinical projects
- Foster collaboration with safety expert panels
- Ensure highest standards of scientific quality
- Lead and develop mechanistic safety associates
- Nurture expertise and scientific excellence
- Build impactful internal and external partnerships
- Advance innovative safety methodologies and best practices
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma AG 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
Novartis Pharma AG
Industry
Pharmaceuticals
Description
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
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