Drug Safety Services

Pharmacovigilance services that serve you.

Like you, patient wellbeing is at our core. That’s why, through the entire post-approval lifecycle, we back you up with the tools to navigate new regulatory requirements with complete drug safety services. We deliver a breadth of services seamlessly, so you can rest assured.

Broad and scalable models

Whether you are looking to partner for case processing support, aggregate reporting, literature searching, medical assessment, or for an end-to-end product portfolio maintenance program, we adapt our solutions to meet your unique needs.

Global reach

The combination of our flexibility and global reach means we have the capacity to support our partners around the globe. In fact, we are currently handling more than 600,000 cases each year.

Industry-leading talent

Our team has a deep understanding of all facets of the biopharmaceutical industry. So from systems reviews, processes, documentation, technology, and more we come to work every day to make the healthcare world better. Our people include:

• Medical Directors and Drug Safety Physicians (with board certification or equivalent)
• Drug Safety Associates, Specialists and Senior Pharmacovigilance Specialists
• Medical Information Technologists (with extensive experience in migrating and establishing safety databases on behalf of clients)
• Parexel Consultants with experience in six sigma, quality and compliance and risk management
• Quality process & training specialists
• Medical writers
• Pharmacoepidemiologists
• QPPV Office providing QPPV and national PV contact person worldwide