Global Pharmacovigilance (PV) Scientist, Senior Manager

Responsibilities

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
• Supports and provides oversight to staff with regards to safety in clinical trials to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
• Review of AEs/SAEs from clinical trials as needed
• 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
• Participate in study team meetings as requested or needed
• Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
• Documents work as required in the safety information management system
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• 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: Provides contents for risk management plans
• Develop or update strategy and content for regional risk management plans
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities, Provide safety contents for filings
• Inspection Readiness - Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Basic Qualifications

• 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

Preferred Qualifications

• BS in Life Science with 3 years drug safety experience, preferably industry pharmacovigilance experience
• Experience in Signal detection, evaluation and management
• Experience of Literature Surveillance: 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 methods of qualitative and quantitative safety data analysis