Idorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Vollzeitnur vor OrtSenior
Allschwil
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IDIdorsia Pharmaceuticals Ltd
Drug Safety Physician(m/w/x)
Allschwil
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Product vigilance for marketed small-molecule drugs, including insomnia treatment QUVIVIQ™, leading early development projects and cross-functional Management Teams. Doctor of Medicine degree and 5+ years global pharma/biotech product vigilance experience required. International exposure.
Anforderungen
- Doctor of Medicine degree
- At least 5 years' experience in global drug safety in pharmaceutical or biotechnology industry
- Full understanding of post-marketing adverse experience reporting systems
- Experience in product safety monitoring
- Experience in preparation of post-marketing regulatory safety reports/documents
- Excellent medical writing skills
- Excellent presentation skills
- Excellent interpersonal skills
- Excellent communication skills
- Excellent negotiation skills
- Excellent organizational capabilities
- Excellent planning capabilities
- Ability to meet timelines
Aufgaben
- Ensure safety for assigned marketed products
- Lead early development projects as the responsible DSP
- Lead the cross-functional Safety Management Team (SMT)
- Integrate, analyze, and interpret safety information from all sources
- Coordinate SMT presentations for the Idorsia DSC
- Ensure accurate review of product safety profiles
- Oversee presentation of safety measures and SMT recommendations
- Manage overall signal detection, monitoring, evaluation, and interpretation of safety information
- Prepare aggregated periodic safety reports (DSUR, PSUR/PBRER)
- Prepare Reference Safety Information (RSI) for IB
- Contribute to key regulatory safety documents, such as RMP
- Conduct medical review of adverse event reports from all sources
- Ensure proper coding, seriousness, expectedness, and causality assessment
- Request medically relevant follow-up for documentation and evaluation
- Respond to safety inquiries from regulatory authorities
- Support regulatory Health Authority inspections
Berufserfahrung
- 5 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Benefits
Weiterbildungsangebote
- Growth and learning opportunities
Lockere Unternehmenskultur
- Collaborative culture
- International exposure
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd 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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IDIdorsia Pharmaceuticals Ltd
Drug Safety Physician(m/w/x)
Allschwil
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Product vigilance for marketed small-molecule drugs, including insomnia treatment QUVIVIQ™, leading early development projects and cross-functional Management Teams. Doctor of Medicine degree and 5+ years global pharma/biotech product vigilance experience required. International exposure.
Anforderungen
- Doctor of Medicine degree
- At least 5 years' experience in global drug safety in pharmaceutical or biotechnology industry
- Full understanding of post-marketing adverse experience reporting systems
- Experience in product safety monitoring
- Experience in preparation of post-marketing regulatory safety reports/documents
- Excellent medical writing skills
- Excellent presentation skills
- Excellent interpersonal skills
- Excellent communication skills
- Excellent negotiation skills
- Excellent organizational capabilities
- Excellent planning capabilities
- Ability to meet timelines
Aufgaben
- Ensure safety for assigned marketed products
- Lead early development projects as the responsible DSP
- Lead the cross-functional Safety Management Team (SMT)
- Integrate, analyze, and interpret safety information from all sources
- Coordinate SMT presentations for the Idorsia DSC
- Ensure accurate review of product safety profiles
- Oversee presentation of safety measures and SMT recommendations
- Manage overall signal detection, monitoring, evaluation, and interpretation of safety information
- Prepare aggregated periodic safety reports (DSUR, PSUR/PBRER)
- Prepare Reference Safety Information (RSI) for IB
- Contribute to key regulatory safety documents, such as RMP
- Conduct medical review of adverse event reports from all sources
- Ensure proper coding, seriousness, expectedness, and causality assessment
- Request medically relevant follow-up for documentation and evaluation
- Respond to safety inquiries from regulatory authorities
- Support regulatory Health Authority inspections
Berufserfahrung
- 5 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Benefits
Weiterbildungsangebote
- Growth and learning opportunities
Lockere Unternehmenskultur
- Collaborative culture
- International exposure
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd 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
Idorsia Pharmaceuticals Ltd
Branche
Pharmaceuticals
Beschreibung
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Noch nicht perfekt?
- Idorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Vollzeitnur vor OrtSeniorAllschwil - Idorsia Pharmaceuticals Ltd
Global Senior Pharmacovigilance QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Novartis
Global Program Safety Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Novartis
Global Program Safety Team Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Novartis Pharma AG
Global Head Mechanistic Safety and Safety Signal Management(m/w/x)
Vollzeitnur vor OrtSeniorBasel