CSL Behring
Global Safety Lead(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Glattbrugg
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
DEDenali Therapeutics Inc
Associate Director, Safety Ops(m/w/x)
Zürich
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global pharmacovigilance operations for neurodegenerative disease therapies. Vendor management and global regulatory expertise required. Pension, medical stipend, equity.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 12 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Pension
Sonstige Zulagen
- Medical stipend
Attraktive Vergütung
- Equity
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Denali Therapeutics Inc erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Takeda Pharmaceuticals International AG
Associate Director, Site Start Up and Maintenance(m/w/x)
Vollzeitnur vor OrtManagementZürich - CSL Behring
Associate Director, Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - Takeda Pharmaceuticals International AG
Associate Director, Senior International Clinical Trial Regulatory Lead(m/w/x)
Vollzeitnur vor OrtManagementZürich - CSL Vifor
Associate Director, Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg
DEDenali Therapeutics Inc
Associate Director, Safety Ops(m/w/x)
Zürich
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global pharmacovigilance operations for neurodegenerative disease therapies. Vendor management and global regulatory expertise required. Pension, medical stipend, equity.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 12 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Betriebliche Altersvorsorge
- Pension
Sonstige Zulagen
- Medical stipend
Attraktive Vergütung
- Equity
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Denali Therapeutics Inc erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Denali Therapeutics Inc
Branche
Pharmaceuticals
Beschreibung
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.
Noch nicht perfekt?
- CSL Behring
Global Safety Lead(m/w/x)
Vollzeitnur vor OrtBerufserfahrenGlattbrugg - Takeda Pharmaceuticals International AG
Associate Director, Site Start Up and Maintenance(m/w/x)
Vollzeitnur vor OrtManagementZürich - CSL Behring
Associate Director, Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - Takeda Pharmaceuticals International AG
Associate Director, Senior International Clinical Trial Regulatory Lead(m/w/x)
Vollzeitnur vor OrtManagementZürich - CSL Vifor
Associate Director, Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg