Pharmacovigilance

Pharmacovigilance

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

A pharmacovigilance outsourcing company should enable its clients to interact with one service provider for all the Pharmacovigilance (PV) and regulatory requirements, which translates into a cost and time effective strategy.

PV SYSTEM ESTABLISHMENT

PharmSEA Counsultancy provide the best services to develop the pharmacovigilance system through the following activities:

• Establishing and summarising pharmacovigilance systems (pharmacovigilance system master file, PSMF) for pharmaceutical companies, including annexes
• Compilation of risk management plans (RMP)
• Conducting internal audits
• Preparation for and assistance with inspections by regulatory authorities