Idorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Full-timeOn-siteSenior
Allschwil
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IDIdorsia Pharmaceuticals Ltd
Drug Safety Physician(m/w/x)
Allschwil
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Benefits
Learning & Development
- Growth and learning opportunities
Informal Culture
- Collaborative culture
- International exposure
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd 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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IDIdorsia Pharmaceuticals Ltd
Drug Safety Physician(m/w/x)
Allschwil
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Benefits
Learning & Development
- Growth and learning opportunities
Informal Culture
- Collaborative culture
- International exposure
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd 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
Idorsia Pharmaceuticals Ltd
Industry
Pharmaceuticals
Description
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Not a perfect match?
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