Global Safety Senior Manager
Amgen
full-time
Posted on:
Location Type: Hybrid
Location: Uxbridge • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
About the role
- Work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations
- Provide scientific and compliance expertise to Global Patient Safety (GPS)
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Perform data analysis to evaluate safety signals and write up analysis results
- Author Safety Assessment Reports and other safety documents and regulatory responses
- Direct the planning, preparation, writing and review of safety portions of aggregate reports
- Prepare presentation of the Global Safety Team’s recommendations on safety issues
- Assist in the development of risk management strategy and activities
- Support activities related to new drug applications and other regulatory filings
- Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
- Provide support for clinical trials to review and provide input to study-related documents
- Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV)
Requirements
- RN, PharmD, MPH or PA
- Extensive direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production
- Knowledge of processes and regulations for pharmacovigilance and risk management
- Clinical/medical research experience
Benefits
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analysissignal detectionadverse event data reviewsafety assessmentregulatory response writingrisk management strategy developmentclinical trial supportperiodic report productionsafety document authoring
Soft skills
communicationorganizationalcollaborationpresentation
Certifications
RNPharmDMPHPA