HomeFact SheetsBionical Emas: Pharmacovigilance

Bionical Emas: Pharmacovigilance.

  • Published 06/01/2021
  • Division Clinical Development
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Post-Marketing Pharmacovigilance at Bionical Emas enables our clients to effectively monitor the safety of their products by utilising our highly experienced team combined with tried and tested processes to deliver a cost-effective solution to outsourced safety activities.

The Capabilities.

  • Setup Global Pharmacovigilance Systems
  • UK based case processing
  • Signal Risk Management
  • Database Validations
  • Regulatory Submissions
  • PBRER/PSUR authoring and management
  • Risk Management Plan authoring
  • Licensed Partner PVG Audits
  • PSMF Creation
  • PVG SOP suite creation
  • Safety Data Exchange Agreements
  • EU QPPV and Network of LQPPV
  • Established suite of SDEAs to meet client requirements

The Benefits.

  • Tailored hands-free PVG
  • Single point of contact via Project Manager
  • A cost-effective business model tailored to providing all or components of post-marketing PVG system
  • Autonomous PVG systems service offering
  • Consolidation of safety information for effective risk management

The Experience.

  • 20 years Experience working with pharmaceutical companies in US, Europe and Asia

  • 5 years Minimum Project Manager Post-Marketing Experience

  • 99% Annual ICSR reporting compliance

We can support you with…


Whether it’s for short term-projects such as preparation of a periodic safety update report (PSUR) or long-term projects such as the establishment and operation of a global pharmacovigilance system, we have experts on hand to support you. Our clients range from virtual biotech companies though small pharma to some of the world’s largest healthcare companies.


How can we support you?

Our dedicated teams of experts are on hand to help should you require any additional resource or further information about our services.

COVID-19 Guidance & Measures

A statement from the Bionical Emas Group on guidance & measures regarding COVID-19 - read here

In relation to staff and visitor safety, we have full risk assessments in place for all of our workplaces. These risk assessments are revisited and updated regularly, to reflect changing risks, knowledge and circumstances, and to reflect evolving Government guidance. We have not placed the risk assessments here on the website as they would become out of date too quickly. However, you are welcome to email info@bionical-emas.com to request access to our most up to date risk assessments applicable to your needs. Please note that all our staff are notified of all applicable risk assessments and updates, along with ‘quick guides’ automatically via our e-learning system.