I know this looks like a very basic topic and may not interest everyone working in the field of Pharmacovigilance. However, please note that numerous companies in developing countries (including the highly populated ones) may not have any Pharmacovigilance department. One of the main reasons why these companies hesitate to create one is because setting up a Pharmacovigilance system may be extremely cost accretive. Outsourcing may be out of the question too. With that fear in mind, these companies are willing to take that risk until they are mandated by regulatory authorities, or after failing a Pharmacovigilance inspection.

What is required for setting up a Pharmacovigilance System?

1. Quality Management System

2. Personnel

3. Infrastructure

4. Sources of Adverse Events

1. Quality Management System

One must have a very effective quality management system (QMS) for a well-functioning Pharmacovigilance system.

These are not limited to:

a) SOPs, Work-Instructions and Guidelines, Forms (including adverse event reporting forms)

b) Quality Assurance and Quality Control

c) Audits – Internal, External and Self-Inspections

d) Training

e) Vendor/business partner management and Agreements (including Safety Data Exchange Agreements)

f) Cross-functional collaboration (including labelling documents)

2. Personnel

These are not limited to:

• CaseProcessing Associates
• Medical Writers
• Medics
• Qualified persons with back-up
• PhVQA & PhVIT personnel

3. Infrastructure

This is not limited to:

1. IT – Safety Database, Internet, etc

2. Phone and Fax

3. Admin – Including Office Space and stationery

4. Archival System

4. Sources of Adverse Events

This is also very important. What if you have the systems, people and infrastructure but no adverse event reports?

1. Medical Information System

2. Sales Representatives and Prescribers or HCPs, pharmacists/ chemists etc

3. Patients/ consumers

4. Literature Management

5. Vendors/ business partners/ distributors etc.

Every pharma company with active marketing authorization needs to set up a Pharmacovigilance system. They may decide whether to have an in-house one, an outsourced one or a combination of both. However, the QMS needs to be robust so as to sustain any audit or inspection.