Pharmacovigilance Manager
Amgen
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • 🇬🇧 United Kingdom
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations
- Provide scientific and compliance expertise as needed to GPS
- Contribute to planning, preparation, writing and review of non-medical portions of aggregate reports
- Work with affiliates and internal Amgen partners regarding deliverables
- Review AE/SAEs from clinical trials as needed
- Review and provide input on study protocols, statistical analysis plans and other clinical study-related documents
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Participate in development of safety-related data collection forms for clinical studies
- Attend study team meetings as requested
- Conduct signal detection, evaluation, and management
- Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO
- Prepare safety assessment reports and other safety documents and regulatory responses
- Search and review adverse event data, literature, and other safety-relevant data for signal detection
- Participate in Safety Governance per Amgen processes
- Prepare presentations of Global Safety Team recommendations on safety issues
- Assist GSOs and Senior Scientists in development of risk management strategy and activities
- Provide content for risk management plans and update regional risk management plans
- Assist coordination and tracking of risk minimization activities
- Prepare responses to regulatory inquiries related to risk management plans under GSO guidance
- Support activities related to new drug applications and other regulatory filings
- Undertake activities delegated by the QPPV and maintain inspection readiness
- Act as point of contact for Health Authority Inspections and Internal Process Audits within remit
Requirements
- Degree educated with directly relevant Global Patient Safety experience
- Clinical/medical research experience
- Experience in a biotech/pharmaceutical setting
- Strong technical competency
- Strong attention to detail and time management
- Strong written communication
- Strong planning and problem solving skills
Benefits
- Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Fully remote setting may be considered
- 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
- Opportunities for career development and professional growth
- Reasonable accommodation for individuals with disabilities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analysissignal detectionsafety assessmentrisk managementclinical trial reviewstatistical analysisaggregate report writingadverse event data reviewsafety document preparationregulatory response preparation
Soft skills
attention to detailtime managementwritten communicationplanningproblem solving