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Selecting and Managing Outsourced Safety Providers

This online course provides information on planning a business outsourcing model, best practices for selecting and managing providers, and regulatory authority expectations for pharmacovigilance agreements.


This course provides an overview of the trends in outsourcing safety functions to contract service providers and examines the reasons for outsourced safety programs. A review of the types of contract service providers, including full service, partial service, niche/safety only, business process outsourcing (BPOs) and knowledge process outsourcing (KPOs), will be presented.  Beginning with an internal assessment and analysis of pharmacovigilance tasks, an outsourcing business plan will be described followed by the vetting and ultimate selection of the outsourced pharmacovigilance partner.  Best practices for management of pharmacovigilance service providers, including governance, will also be discussed.  Finally, inspections of outsourced safety service providers, including regulatory authority expectations for pharmacovigilance agreements between sponsors/marketing authorization holders and contract service providers, will be presented.

This module takes an average of 1.25 hours to complete.


    • The Current and Future Landscape of Pharmacovigilance
    • Defining a Safety Program's Needs
    • Outsourced Safety Providers
    • Transfer of Responsibilities
    • Offshoring and Outsourcing
    • Risks and Issues
    • Developing an Outsourced Safety Program
    • Internal Assessment
    • Planning a Business Outsourcing Model
    • Successful Selection of an Outsourced Provider
    • The Sponsor and Contract Service Provider Relationship
    • Safety Outsourcing Provider Management
    • Pharmacovigilance Inspection Programs
    • Inspections in US, EU, and UK
    • Inspection Findings


  • This program is designed for professionals involved in:

    • Drug Safety and Pharmacovigilance
    • Vendor Management
    • Project Management
    • Clinical Research


      • Upon completion of this module, learners should be able to:

        • Assess the need for a contract service provider and the services required
        • Recognize the selection and qualification process of a contract service provider for safety services
        • Identify best practices for managing an outsourcing vendor relationship
        • Determine how regulatory authorities inspect contract service providers to verify compliance with safety regulations
        • Define regulatory authority expectations for content of pharmacovigilance agreements