PHARMACOVIGILANCE SYSTEMS CONSULTING

Pharmacovigilance Systems Consulting is a French consultancy firm providing pharmacovigilance services for the pharmaceutical and biopharmaceutical industry worldwide. Headquartered in Nogent-sur-Marne, France. Here are key aspects of the company:

• Products & Services: Developing and maintaining Pharmacovigilance Systems and Quality Systems; provision of Qualified Person Responsible for Pharmacovigilance (QPPV) and back-up roles in the EU; developing risk management systems and strategy; creating pharmacovigilance system master files; managing inspections, audits, process reviews, gap analyses, and improvements; preparing Periodic Safety Update Reports and conducting benefit-risk analysis; executing post-authorisation safety studies and signal management; handling safety communication; preparing Safety Data Exchange Agreements (SDEA/PVA); and providing ad hoc medical expertise and training.
• Customers & Industries Served: Clients in the pharmaceutical and biopharmaceutical industry across various therapeutic areas, including orphan drugs, with products either authorised or under development, operating globally in the EU/EEA, USA, and Japan. Pharmacovigilance Systems Consulting specializes in comprehensive regulatory compliance and safety management solutions for global life sciences companies.