Pharmacovigilance

Post marketing and clinical development routine reporting and risk management, including PBRER, DSUR, EU RMP, Signal evaluations, MedDRA coding, causality assessment, 15-day alerts, IB  and ICF updates and any other pharmacovigilance needs from a global drug safety or local reporting perspective.

Pharmora offers end-to-end pharmacovigilance services covering the entire clinical development programme through submission and beyond.

The flexible approach offered by Pharmora allows a seamless interface with your organisation to fill any gaps and ensure regulatory compliance with your pharmacovigilance requirements.

Organisations currently benefiting from Pharmora pharmacovigilance support range from large global pharma to academic research units and biotechnology companies.

Therapy areas include oncology, biotechnology, immuno-oncology, nutritionals and medical devices.

We offer a wide range of:

  • Pharmacovigilance Expertise
    • PSUR/PBRER, DSUR, clinical study reports
    • ad hoc post-marketing signal evaluations
  • Regulatory support:
    • Clinical Overviews (Clinical Expert Reports) to support submissions including licence variations
  • Benefit risk evaluations
  • Patient Safety Risk Management Plan (including the new EU RMP template) or FDA Risk Evaluation Mitigation Strategy (REMS)

In addition to providing a suite of services from our offices, Pharmora can also provide pharmaceutical physicians or pharmacovigilance scientists for in-house projects, arrange consultants for short-term contracts or provide tailored training packages for your staff in house.

For more information please get in touch.