Consultations on Pharmacovigilance System implementation

Pharmacovigilance is highly important for pharmaceutical companies. It deals with the major aspects of any drug formulation. The two most important aspects of pharmacovigilance are to make sure the drug works and decode the safety signals.

The pharmacovigilance services are divided into four major categories i.e., Pharmacovigilance surveillance, Pharmacovigilance operations, Qualified Person for Pharmacovigilance, and Pharmacovigilance database and systems.

Most often pharma companies have a lot of things to deal with, this is why they need a trusted qualified pharmacovigilance partner to outsource PV activities.

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• IGRS is the pharmacovigilance service provider that complies with national and international regulations.

• Our team has medical and scientific experts with years of experience in the areas of pharmacovigilance.

• We provide support and guidance in updating or developing working practices and standard operating procedures that support pharmacovigilance activities as follows:

• Handling of ICSRs, aggregate reporting, signal detection and other pharmacovigilance process

• Preparations of Safety data exchange agreement maintenance

• Risk minimization activities and signal management

• Safety Narratives (Brief and Full Narratives)

• Handling safety information from medical enquires and product quality complaints

• Maintenance and development of core datasheet

• Employees PV training

• Supports audit-related activities including audit plan, audit findings, audit program, audit recommendations etc.