Global Pharmacovigilance Safety, Senior Manager- Obesity
Global Pharmacovigilance Senior Manager
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Directs the planning, preparation, writing and review of portions of aggregate reports
Organize and direct liaison for activities with affiliates and other internal Amgen partners regarding products
Supports and provides oversight to staff with regards to safety in clinical trials
Reviews and provides input and support on study protocols, statistical analysis plans and other clinical study-related documents
Reviews AEs/SAEs from clinical trials as needed
Participates in development of safety-related data collection forms for clinical studies
Participates in study team meetings as requested or needed
Performs data analysis to evaluate safety signals and write up analysis results
Documents work as required in the safety information management system
Authors Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSOS
Searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal detection
Prepares presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
Evaluates risk management strategy and activities
Develops or updates strategy and content for regional risk management plans
Aids GSO in the development of risk management strategy and activities
Assists GSO in overseeing risk minimization activities including tracking of activities as needed
Prepares response to regulatory inquiries related to risk management plans under the guidance of GSO
Supports activities related to new drug applications and other regulatory filings
Assists GSO in developing a strategy for safety-related regulatory activities
Provides safety contents for filings
Undertakes activities delegated by the QPPV as detailed in the PV System Master File and maintains a state of inspection readiness
Represents and points 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
Master’s degree and 4 years of industry pharmacovigilance experience
Bachelor's degree and 6 years of industry pharmacovigilance experience
Associate’s degree and 10 years of industry pharmacovigilance experience
High school diploma/GED and 12 years of industry pharmacovigilance experience
Preferred Qualifications
Bachelor’s in life science and Master’s and 6 years of related experience
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