High-Volume Global Pharmacovigilance Onboarding
A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding timelines, and the challenge of training large, distributed teams placed data quality, compliance, and inspection readiness at risk during a critical growth phase.
ProPharma partnered with the sponsor to deliver rapid, scalable global onboarding — deploying a phased onboarding model, a dedicated training team, and embedded QA oversight to ensure consistent role readiness and regulatory alignment. Supported by safety database expertise and automation, ProPharma enabled uninterrupted ICSR processing while maintaining quality at scale.
Within 12 months, ProPharma onboarded more than 1,000 pharmacovigilance professionals globally, including surge deployment of over 400 resources in a single month. The partnership delivered sustained compliance, consistent case quality, and a resilient PV operating model that continues to support high-volume global safety operations.
Related Resources
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
Navigating the Generic Drug Application and Approval Process
Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...