Global Pharmacovigilance Scientist, Senior Manager

Jobtailor; Deutschland; Remote; EUR 70.000 - 110.000; Vollzeit

Jobbeschreibung

• 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