SSI Strategy About Us

Our company    Leadership    Advisors

SSI Strategy was launched in early 2011 to serve a growing need for pragmatic and effective PV advisory services and no-nonsense PV Service.  Our team is passionate about safety yet has an uncommon and well developed commercial sensitivity.  We take great pride in helping PV organizations demonstrate how safety adds value to the broader corporation.

We have significant experience with all aspects of PV, including managing, advising, and rolling up our sleeves.  Our experience spans PV, Regulatory Affairs, Product Development, Business Development, and Commercial, and is coupled with formal consulting experience at top tier firms.
SSI has a unique structure, a combination of internal (SSI Team) and external (Scientific and Business Advisors, Partners, Affiliates, and Independant Consultants) that comes together precisely to meet the needs of our clients.

SSI provides guidance on proper setup of effective, efficient, and compliant internal or external safety operations to best suit the client's business model.  We have experience preparing business cases and proposals for senior management to ensure buy-in for whichever safety system makes most sense.  SSI Strategy is keenly aware of the resource drain associated with multiple vendor interactions and decided, early on, to offer to provide world class PV Services in addition to advice.  We offer an entire suite of additional services (either directly or via trusted partners).

Services include:

  • PV Consulting Services
    • Pharmacovigilance Business Strategy
    • Safety System Review
    • Safety operation/organization design
    • Product Safety Governance Advising
    • Sourcing and Vendor Strategy Optimization
    • Quality Management System design
  • PV Services
    • Virtual Head of Safety
    • Scientific Support - Signal Detection, Analysis, and Decision Support
    • Safety Document Preparation - benefit/risk, aggregate reports, RMP, REMS
    • Clinical Trials and Registry Design and Execution
    • Safety Marketing Support - Monitored/Controlled/Performance-Based Distribution
    • Inspection Support
    • Training and Documentation Support