Senior Global Safety Manager, Rare Disease
Amgen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $148,053 - $172,515 per year
Job 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 in collaboration with the Global Safety Officer (GSO)
- 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 to the cross-functional decision-making body
- Assist GSO 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
Requirements
- Doctorate degree and 2 years of proven experience OR Master’s degree and 4 years of proven experience OR Bachelor’s degree and 6 years of proven experience OR Associate’s degree and 10 years of proven experience OR High school diploma / GED and 12 years of proven experience
- RN, PharmD, MPH or PA Preferred
- 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
- A comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements
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 authoringdata interpretation
Soft skills
collaborationcommunicationorganizational skillspresentation skillsleadershipplanningreviewingdirecting
Certifications
Doctorate degreeMaster’s degreeBachelor’s degreeAssociate’s degreeRNPharmDMPHPA