CSL Behring
Global Safety Lead(m/w/x)
Full-timeOn-siteExperienced
Glattbrugg
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DEDenali Therapeutics Inc
Associate Director, Safety Ops(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
Global pharmacovigilance operations for neurodegenerative disease therapies. Vendor management and global regulatory expertise required. Pension, medical stipend, equity.
Requirements
- Bachelor’s degree and 12+ years relevant experience or equivalent education/experience
- Strong focus on pharmacovigilance safety operations in global environment
- Expertise in global pharmacovigilance regulations and guidelines
- Experience managing vendors and external partners
- Ability to lead complex, cross-functional initiatives
- Ability to manage multiple priorities
- Experience supporting regulatory inspections and audits
- Strong communication skills
- Strong organizational skills
- Strong problem-solving skills
- Ability to operate effectively in fast-paced, matrixed environment
- Experience in pre-approval pharmacovigilance activities
- Experience in post-marketing pharmacovigilance activities
Tasks
- Lead global pharmacovigilance operations for assigned clinical programs
- Ensure compliant safety case intake, processing, and reporting
- Oversee safety case reconciliation across all sources
- Manage safety case activities to meet global regulatory requirements
- Ensure adherence to company procedures and reporting timelines
- Manage pharmacovigilance vendors and external partners
- Ensure vendor performance and compliance
- Align vendors with contractual and operational expectations
- Lead development of safety data exchange agreements
- Lead development of PV agreements with license partners
- Drive continuous improvement of pharmacovigilance processes
- Drive continuous improvement of pharmacovigilance systems
- Drive continuous improvement of pharmacovigilance workflows
- Enhance efficiency and quality of pharmacovigilance operations
- Lead planning of aggregate safety reports
- Lead operational delivery of aggregate safety reports
- Partner cross-functionally with Clinical, Regulatory, and Safety Science
- Ensure effective adverse event handling and communication
- Monitor pharmacovigilance compliance metrics
- Identify trends in compliance metrics
- Implement corrective and preventive actions
- Support regulatory inspections and audits
- Support inspection readiness activities
- Prepare documentation for inspections
- Prepare responses for inspections
- Contribute to pharmacovigilance procedure development
- Contribute to pharmacovigilance procedure maintenance
- Ensure organizational awareness of pharmacovigilance procedures
- Ensure organizational compliance with pharmacovigilance procedures
- Support safety-related inputs into clinical documents
- Support safety-related inputs into regulatory documents
- Support safety procedures for international market expansion
Work Experience
- 12 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Retirement Plans
- Pension
Additional Allowances
- Medical stipend
Competitive Pay
- Equity
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Denali Therapeutics Inc 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.
Not a perfect match?
- CSL Behring
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Full-timeOn-siteSeniorGlattbrugg
DEDenali Therapeutics Inc
Associate Director, Safety Ops(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
Global pharmacovigilance operations for neurodegenerative disease therapies. Vendor management and global regulatory expertise required. Pension, medical stipend, equity.
Requirements
- Bachelor’s degree and 12+ years relevant experience or equivalent education/experience
- Strong focus on pharmacovigilance safety operations in global environment
- Expertise in global pharmacovigilance regulations and guidelines
- Experience managing vendors and external partners
- Ability to lead complex, cross-functional initiatives
- Ability to manage multiple priorities
- Experience supporting regulatory inspections and audits
- Strong communication skills
- Strong organizational skills
- Strong problem-solving skills
- Ability to operate effectively in fast-paced, matrixed environment
- Experience in pre-approval pharmacovigilance activities
- Experience in post-marketing pharmacovigilance activities
Tasks
- Lead global pharmacovigilance operations for assigned clinical programs
- Ensure compliant safety case intake, processing, and reporting
- Oversee safety case reconciliation across all sources
- Manage safety case activities to meet global regulatory requirements
- Ensure adherence to company procedures and reporting timelines
- Manage pharmacovigilance vendors and external partners
- Ensure vendor performance and compliance
- Align vendors with contractual and operational expectations
- Lead development of safety data exchange agreements
- Lead development of PV agreements with license partners
- Drive continuous improvement of pharmacovigilance processes
- Drive continuous improvement of pharmacovigilance systems
- Drive continuous improvement of pharmacovigilance workflows
- Enhance efficiency and quality of pharmacovigilance operations
- Lead planning of aggregate safety reports
- Lead operational delivery of aggregate safety reports
- Partner cross-functionally with Clinical, Regulatory, and Safety Science
- Ensure effective adverse event handling and communication
- Monitor pharmacovigilance compliance metrics
- Identify trends in compliance metrics
- Implement corrective and preventive actions
- Support regulatory inspections and audits
- Support inspection readiness activities
- Prepare documentation for inspections
- Prepare responses for inspections
- Contribute to pharmacovigilance procedure development
- Contribute to pharmacovigilance procedure maintenance
- Ensure organizational awareness of pharmacovigilance procedures
- Ensure organizational compliance with pharmacovigilance procedures
- Support safety-related inputs into clinical documents
- Support safety-related inputs into regulatory documents
- Support safety procedures for international market expansion
Work Experience
- 12 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Retirement Plans
- Pension
Additional Allowances
- Medical stipend
Competitive Pay
- Equity
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Denali Therapeutics Inc 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
Denali Therapeutics Inc
Industry
Pharmaceuticals
Description
Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through its deep commitment to degeneration biology and principles of translational medicine.
Not a perfect match?
- CSL Behring
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Full-timeOn-siteSeniorGlattbrugg