Management Challenge:
- This US biotechnology company’s Pharmacovigilance (PV) organisation wanted to understand how they were performing relative to other similar-sized companies with respect to their setup, operations, capabilities, technologies, and sourcing strategy
- They exercise was intended to support critical business decisions relating to the optimal operating model that was needed for their future state activities and product launch timeline.
Project Setup
- Sourced through a partner consulting team who identified the need for a subject matter expert to liaise with the client and manage stakeholders throughout the engagement
- Conducted virtually: client team were all US-based, independent consultant was based in the UK.
Approach & Solution
- Key sponsors: Chief Medical Officer and Head of PV (Safety)
- Interviewed a range of stakeholders from within the PV organisation as well as interfaced functions, including Clinical, Regulatory, Quality, and IT
- Assessed the company’s performance against similarly sized companies with respect to operating model, organisation structure, technology aspirations, and sourcing approach
- Provided a compliance dashboard based on a review of their procedural documentation and associated
- Identified and documented a set of prioritised gaps for remediation, including critical actions and a roadmap for operational excellence
Benefits & Outcome
- Allowed the client to better understand their internal operations and how to optimally interface with internal and external stakeholders
- Provided a set of actionable outcomes to enable the PV organisation to progress
Conceptualised how PV could operate optimally and in a compliant manner, with critical performance metrics driving change
