Global Pharmacovigilance Scientist, Senior Manager
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Job Description
Senior Manager leading global pharmacovigilance assessments for Amgen’s biotech medicines. Directing signal detection, aggregate reports, risk management, regulatory filings, and inspection readiness.
Responsibilities:
- Work with Therapeutic Safety Teams on safety assessment activities for medical/scientific operations
- Direct planning, preparation, writing and review of portions of aggregate reports
- Organize and direct liaison activities with affiliates and internal Amgen partners regarding products
- Support and provide oversight to staff regarding clinical-trial safety
- Review and provide input on study protocols, statistical analysis plans and other clinical study documents
- Review adverse events and serious adverse events from clinical trials as needed
- Review standard safety-data tables, figures and listings
- Participate in developing safety-related data collection forms and study team meetings
- Perform signal detection, evaluation and management through safety-data analysis
- Document work in the safety information management system
- Author Safety Assessment Reports, safety documents and regulatory responses with the GSO
- Search and review adverse-event data, literature and other safety-relevant data for signal detection
- Present Global Safety Team recommendations to cross-functional decision-making bodies
- Assist with risk-management strategies, plans, risk minimization activities and regulatory inquiries
- Support safety-related activities for new drug applications and other regulatory filings
- Undertake delegated QPPV activities and maintain inspection readiness
- Serve as representative and point of contact for Health Authority Inspections and Internal Process Audits
Requirements:
- Doctorate degree and 2 years of industry pharmacovigilance experience, OR Master’s degree and 4 years of industry pharmacovigilance experience, OR Bachelor’s degree and 6 years of industry pharmacovigilance experience, OR Associate’s degree and 10 years of industry pharmacovigilance experience, OR high school diploma/GED and 12 years of industry pharmacovigilance experience
- Experience in signal detection, evaluation and management
- Experience of literature surveillance, including source document review knowledge and skills
- Experience in aggregate data analysis, interpretation and synthesis
- Good clinical and scientific judgment
- Clinical and/or medical research experience
- Understanding of qualitative and quantitative safety data analysis methods
- Sponsorship for this role is not guaranteed
Benefits:
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance support
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