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