We worked with a biopharma organization to improve their pharmacovigilance capability.
A global biopharma recognized it needed to revamp its pharmacovigilance capability to keep pace with the company’s growth. It undertook a major, multi-year partnership with an industry leading technology firm to develop a new pharmacovigilance technology platform leveraging cognitive computing. The program faced significant business, technological, and regulatory complexities, compounded by the partnership with the external technology firm.
We were engaged to provide critical program management support during the mobilization and launch of the technology aspects of the initiative. We established a PMO; developed key PMO structures, processes and deliverables; and facilitated consensus building and issue resolution on a day-to-day basis to advance the program. Additionally, we worked with the external technology firm and our client’s various internal stakeholder groups (e.g. PV, IT) to develop the program operating model and governance.
As a result of our support, our client’s pharmacovigilance program was initiated with solid program management structures in place. All key planning milestones were met, allowing for the proper scoping of subsequent phases of the multi-year program.