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Fact Sheet: Pharmacovigilance

6 January 2021

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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.