Pharmacovigilance and Risk Management

Our senior safety physicians and scientists are experts in designing, implementing and leading full risk management and pharmacovigilance (PV) programmes. This experience allows us to maintain a broad, global perspective when it comes to achieving regulatory approvals, securing label extensions and monitoring safety.

Experienced, hands-on, drug safety services specialists are vital when negotiating the complex maze of global PV regulations.

Our drug safety and PV team works on a multitude of projects, from early clinical development through to post-licensing PV.

How do we support you?

How do we support you?

Our team of tranScrip experts helps with everything from PV inspection readiness and training, to planning for post-approval safety studies. Along the way, we also supply end-to-end safety signal management and access to a regulatory compliant in-house safety database.

The support we offer doesn't end there. Our specialists assist with Data and Safety Monitoring Board (DSMB) activities and offer guidance for any relevant drug safety training programmes. We can also provide a Qualified Person for Pharmacovigilance consultancy (EU/UK).

Safety writing

In terms of safety writing, every conceivable requirement is met by our team.

That includes:

  • Developmental safety update reports
  • Periodic risk benefit evaluation reports
  • Safety responses to health authority requests (pre- and post-approval)
  • Risk management plans
  • Developmental risk management plans
  • Safety narrative writing

Capability Overview

09 May 23

Contact our team of experts

We have teams of life science and R&D experts to help achieve your goals and seize opportunities. Whatever your project requires, we have the people to meet your needs.