Navitas Life Sciences

PV Safety Benefit Risk Management Optimisation and Integration

An international pharmaceutical company growing rapidly through multiple simultaneous acquisitions was severely challenged to integrate a variety of diverse pharmacovigilance (PV) operating processes into one harmonised system.

Recent Health Authority inspections and internal audits highlighted a number of compliance issues related to process inconsistencies and regulatory shortcomings.

To help address these issues, Navitas was engaged to develop and implement a new integrated operating model.

 

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