Idorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Full-timeOn-siteSenior
Allschwil
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F.F. Hoffmann-La Roche AG
Senior Safety Scientist(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Defining risk management strategies for new medicines and coordinating pharmacovigilance activities. 4+ years drug development experience required. Support for early and late-phase development.
Requirements
- Qualified healthcare professional or Life Sciences graduate
- Preferred postgraduate qualification (PHD/MSc in Life sciences, PharmD)
- 4+ years drug development experience
- At least 2 years in drug safety or related field
- Strong understanding of GxP
- Understanding of regulated processes
- Understanding of end-to-end clinical trial lifecycle
- Excellent written communication skills
- Excellent verbal communication skills
- Effective collaboration with remote partners
- Adept at complex data analysis
- Adept at statistical methods
- Evaluate scientific data
- Interpret scientific data
- Present scientific data clearly
- Strong presentation skills
- Summarize key considerations
- Present key decision points
- Ability to act independently
- Minimal supervision required
- Manage safety responsibilities
- Support safety science activities
Tasks
- Deliver knowledge on medicine safety profiles
- Define risk management strategies for patients
- Coordinate pharmacovigilance system activities
- Provide safety science and pharmacovigilance support
- Influence early and late-phase development activities
- Offer safety oversight in study management
- Lead post-market safety activities
- Evaluate safety signals
- Assess benefit-risk
- Manage comprehensive safety risks
- Own individual and aggregate case reporting
- Handle ICSR case management
- Prepare critical aggregate reports (DSUR, PBRER)
- Drive signal detection and management
- Maintain STAR and ISMP
- Contribute to strategic safety reviews
- Influence product safety strategy
- Provide drug safety input into Clinical Development
- Prepare and maintain CCDS
- Update labeling documents (including IB)
- Develop risk communications
- Maintain RMP and REMS
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche AG 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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F.F. Hoffmann-La Roche AG
Senior Safety Scientist(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Defining risk management strategies for new medicines and coordinating pharmacovigilance activities. 4+ years drug development experience required. Support for early and late-phase development.
Requirements
- Qualified healthcare professional or Life Sciences graduate
- Preferred postgraduate qualification (PHD/MSc in Life sciences, PharmD)
- 4+ years drug development experience
- At least 2 years in drug safety or related field
- Strong understanding of GxP
- Understanding of regulated processes
- Understanding of end-to-end clinical trial lifecycle
- Excellent written communication skills
- Excellent verbal communication skills
- Effective collaboration with remote partners
- Adept at complex data analysis
- Adept at statistical methods
- Evaluate scientific data
- Interpret scientific data
- Present scientific data clearly
- Strong presentation skills
- Summarize key considerations
- Present key decision points
- Ability to act independently
- Minimal supervision required
- Manage safety responsibilities
- Support safety science activities
Tasks
- Deliver knowledge on medicine safety profiles
- Define risk management strategies for patients
- Coordinate pharmacovigilance system activities
- Provide safety science and pharmacovigilance support
- Influence early and late-phase development activities
- Offer safety oversight in study management
- Lead post-market safety activities
- Evaluate safety signals
- Assess benefit-risk
- Manage comprehensive safety risks
- Own individual and aggregate case reporting
- Handle ICSR case management
- Prepare critical aggregate reports (DSUR, PBRER)
- Drive signal detection and management
- Maintain STAR and ISMP
- Contribute to strategic safety reviews
- Influence product safety strategy
- Provide drug safety input into Clinical Development
- Prepare and maintain CCDS
- Update labeling documents (including IB)
- Develop risk communications
- Maintain RMP and REMS
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche AG 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
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