Resource

Fact Sheet: Pharmacovigilance

6 January 2021

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…

Pharmacovigilance

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.