Senior Manager, Global Pharmacovigilance Safety – Obesity

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
• 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
• Maintain a state of inspection readiness.

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
• Bachelor’s in life science
• 2 years of managerial experience directly managing people or projects and/or mentoring experience
• Clinical or medical research experience
• 6 years of experience in the biotech/pharmaceutical setting

Core Competencies

Demonstrates expertise in pharmacovigilance, including safety signal detection, risk management strategies, and regulatory compliance. Proficient in clinical trial oversight, data analysis, and authoring safety assessment reports.