Denali Therapeutics Inc
Associate Director, Safety Ops(m/w/x)
Full-timeOn-siteSenior
Zürich
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Clinical safety evaluation for gene therapies, ensuring product safety and compliance. MD or equivalent with patient care and industry experience required. 4-day work week, company car for private use.
Requirements
- Strong product knowledge
- Gene Therapy safety experience
- MD or international equivalent
- Physician experience in patient care
- Industry experience
- Safety & PV roles experience
- Gene therapy safety experience
- Scientific data knowledge
- Hematology knowledge
- Competitive landscape knowledge
- Data management skills
- Statistical methods skills
- Benefit–Risk assessment skills
- Signal and Risk Management
- Technology use in signal detection
- Risk prediction skills
- Mitigation strategy drafting skills
- PV & RnD acumen
- PV concepts knowledge
- PV documents knowledge
- Safety sections of regulatory documents knowledge
- Labeling principles knowledge
- Regional labeling differences knowledge
- Product development knowledge
- Cross‑functional scientific principles knowledge
- Due diligence processes knowledge
Tasks
- Provide expertise on clinical safety throughout the product lifecycle
- Evaluate safety information during clinical development and post-approval
- Ensure alignment with safety objectives and company PV standards
- Comply with legal requirements for product safety
- Prevent harm from adverse reactions
- Promote safe and effective use of medicinal products
- Contribute to patient and public health protection
- Apply medical judgment to analyze complex clinical safety data
- Detect safety signals
- Initiate safety risk management activities
- Develop safety specifications
- Plan pharmacovigilance activities
- Implement risk minimization and mitigation strategies
- Integrate safety risk management into medical, business, and regulatory contexts
- Serve as safety representative in cross-functional development teams
- Serve as safety representative in post-marketing product teams
- Set safety strategy for global projects
- Oversee safety management teams for consistent safety data review
- Oversee signal detection and evaluation
- Oversee analysis of aggregate safety data
- Produce DSURs, PSURs, and RMPs
- Ensure timely production of aggregate reports
- Provide timely responses to Health Authorities regarding patient safety
- Address inspection and internal audit findings
- Oversee safety sections of protocols, IBs, ICFs, and CSRs
- Develop core safety information
- Review ISS and SCS
- Provide guidance on medical, product, and process matters
- Chair the Safety Management Team (SMT)
- Represent GSPV cross-functionally
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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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Clinical safety evaluation for gene therapies, ensuring product safety and compliance. MD or equivalent with patient care and industry experience required. 4-day work week, company car for private use.
Requirements
- Strong product knowledge
- Gene Therapy safety experience
- MD or international equivalent
- Physician experience in patient care
- Industry experience
- Safety & PV roles experience
- Gene therapy safety experience
- Scientific data knowledge
- Hematology knowledge
- Competitive landscape knowledge
- Data management skills
- Statistical methods skills
- Benefit–Risk assessment skills
- Signal and Risk Management
- Technology use in signal detection
- Risk prediction skills
- Mitigation strategy drafting skills
- PV & RnD acumen
- PV concepts knowledge
- PV documents knowledge
- Safety sections of regulatory documents knowledge
- Labeling principles knowledge
- Regional labeling differences knowledge
- Product development knowledge
- Cross‑functional scientific principles knowledge
- Due diligence processes knowledge
Tasks
- Provide expertise on clinical safety throughout the product lifecycle
- Evaluate safety information during clinical development and post-approval
- Ensure alignment with safety objectives and company PV standards
- Comply with legal requirements for product safety
- Prevent harm from adverse reactions
- Promote safe and effective use of medicinal products
- Contribute to patient and public health protection
- Apply medical judgment to analyze complex clinical safety data
- Detect safety signals
- Initiate safety risk management activities
- Develop safety specifications
- Plan pharmacovigilance activities
- Implement risk minimization and mitigation strategies
- Integrate safety risk management into medical, business, and regulatory contexts
- Serve as safety representative in cross-functional development teams
- Serve as safety representative in post-marketing product teams
- Set safety strategy for global projects
- Oversee safety management teams for consistent safety data review
- Oversee signal detection and evaluation
- Oversee analysis of aggregate safety data
- Produce DSURs, PSURs, and RMPs
- Ensure timely production of aggregate reports
- Provide timely responses to Health Authorities regarding patient safety
- Address inspection and internal audit findings
- Oversee safety sections of protocols, IBs, ICFs, and CSRs
- Develop core safety information
- Review ISS and SCS
- Provide guidance on medical, product, and process matters
- Chair the Safety Management Team (SMT)
- Represent GSPV cross-functionally
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Not a perfect match?
- Denali Therapeutics Inc
Associate Director, Safety Ops(m/w/x)
Full-timeOn-siteSeniorZürich - CSL Behring
Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring
Director, Sr. Global Regulatory Lead - Cardiorenal(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Plasma
Principal Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSeniorOpfikon - CSL Behring
Principal Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSeniorGlattbrugg