Senior Manager, Safety Data Science (FTC Maternity Cover)

Tasks

• Analyze safety data from safety databases
• Assess benefit risk impact
• Author global aggregate safety reports
• Communicate safety findings to product teams
• Conduct safety signal evaluation
• Develop strategies for signal assessments
• Lead safety related initiatives
• Maintain safety sections of clinical documents
• Mentor and train safety scientists
• Perform safety signal detection
• Prepare materials for regulatory safety requests
• Prepare safety data summaries for safety meetings
• Prepare written and verbal signal management summaries
• Review safety data from clinical trials
• Review safety literature

Perks/Benefits

• N/A

Skills/Tech-stack

Benefit-risk assessment | Clinical Summary of Safety | Clinical study | Clinical study reports | Clinical trials | Company Core Data Sheets | Data sheets | Drug development | Medical judgment | Microsoft Excel | Microsoft Word | Pharmacovigilance | Project Management | Regulatory Reporting | Risk Assessment | Risk Management | Risk Management Plan | Safety Databases | Signal Detection | Signal evaluation