Director, Safety Scientist
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $185,100 - $245,100 per year
Job Level
About the role
- Support assigned compounds with safety signal detection
- Lead the detection of safety signals from various data sources
- Analyze safety data and author safety assessments
- Collaborate with PSLs and cross-functional teams
- Prepare and present safety data at governance meetings
- Lead safety section authoring for regulatory submissions
- Conduct risk assessment and respond to regulatory inquiries
Requirements
- PharmD, NP, RN, or PhD in a medical field or biological science
- 8+ years of experience as a Safety Scientist
- 4+ years of clinical experience with patients in a relevant therapeutic area specialty
- Significant knowledge of general medicine
- 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research
- Advanced knowledge of safety database (i.e., Argus)
- Advanced knowledge of MedDRA and signal management system
- Advanced application capability with Excel, PowerPoint, Word
- Experience with data mining tools and analyses tools such as Spotfire and PowerBI
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
safety signal detectionsafety data analysissafety assessmentsrisk assessmentregulatory submissionsdata miningsignal managementclinical developmentclinical researchgeneral medicine
Soft Skills
collaborationpresentation skillsleadership
Certifications
PharmDNPRNPhD