Denali Therapeutics Inc
Associate Director, Safety Ops(m/w/x)
Vollzeitnur vor OrtSenior
Zürich
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
CSCSL Behring
Global Safety Lead(m/w/x)
Glattbrugg
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring 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.
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Vollzeitnur vor OrtSeniorOpfikon - CSL Behring
Principal Scientist, Regulatory Toxicology(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg
CSCSL Behring
Global Safety Lead(m/w/x)
Glattbrugg
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring 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
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Noch nicht perfekt?
- Denali Therapeutics Inc
Associate Director, Safety Ops(m/w/x)
Vollzeitnur vor OrtSeniorZürich - CSL Behring
Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - CSL Behring
Director, Sr. Global Regulatory Lead - Cardiorenal(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - CSL Plasma
Principal Scientist, Regulatory Toxicology(m/w/x)
Vollzeitnur vor OrtSeniorOpfikon - CSL Behring
Principal Scientist, Regulatory Toxicology(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg