BeOne Medicines
Cancer has no borders. Neither do we.
Director, Safety Scientist
Location
United States
Posted
45 days ago
Salary
$185.1K - $245.1K / year
Professional Certificate8 yrs expEnglish
Job Description
• 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
Job 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
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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