- 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
Core Competencies
Demonstrates expertise in pharmacovigilance, including signal detection, evaluation, and management, while effectively collaborating with cross-functional teams to ensure safety assessment and regulatory compliance. Proficient in aggregate data analysis and documentation within safety information management systems.
Highest-signal resume keywords
- Pharmacovigilance Experience
- Signal Detection, Evaluation, And Management
- Aggregate Data Analysis
- Clinical Research Experience
- Safety Assessment Reporting
Hard Skills
- Signal Detection
- Data Analysis
- Aggregate Report Writing
- Safety Data Management
- Adverse Event Review
- Statistical Analysis Plans
- Risk Management Strategies
- Safety Document AuthoringLiterature Surveillance
- Clinical Trial Oversight
Soft Skills
- Good Clinical Judgment
- Interpersonal Communication
Industry Keywords
- Therapeutic Safety
- Clinical Trials
- Regulatory Filings
- Health Authority Inspections
- QPPV Activities
Tools & Technologies
- Safety Information Management System
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Global Pharmacovigilance Scientist, Senior Manager Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
