Patient safety (Pharmacovigilance)

Gain improved regulatory compliance and patient safety through rigorous risk management, data management, and quality assurance practices. Effectively navigate complex regulatory landscapes and optimize your PV processes with our global expertise and tailored solutions. Pharmacovigilance system governance services include a qualified person for pharmacovigilance (QPPV), a pharmacovigilance system master file (PSMF), PV agreement management, quality management systems, training, and PV audits. 

We help companies navigate complex regional and local pharmacovigilance regulatory requirements to streamline expansion to new markets, facilitate growth in current markets, and gain workload flexibility without compromising quality. Quickly scale with expert local staff to meet country-specific safety mandates, supporting growth objectives while reducing regulatory and revenue risk. Patient safety services include a national PV contact person, local literature surveillance, local individual case study reports (ICSR) management, local PV intelligence, and analyses of local medical literature related to pharmacovigilance.

With a focus on efficiency and expertise, Cencora enhances your pharmacovigilance operations, allowing your team to concentrate on strategic priorities. We provide end-to-end management of safety data, from case processing to regulatory reporting, supporting timely and accurate compliance with global standards. Our operational services include literature surveillance, ICSR management, and safety reports.

A product’s benefit-risk profile is continuously changing over its life cycle, so we create a data-driven, multi-source composite snapshot of your product’s benefit-risk profile to guide a variety of key decisions and regulatory communications. Your benefits can outweigh your risks with a well-managed, proactive approach.