Drug Safety Services

Integrated Pharmacovigilance Services

With the introduction of new regulatory requirements governing post-approval pharmacovigilance, means the pressure on biopharmaceutical companies is ever increasing.

PAREXEL understands that patient safety is at the heart of every company’s focus. This is why we are committed to delivering quality, integrated drug safety services across the full spectrum of the post-approval life cycle.

Our seamless execution, breadth of services, deep expertise and a highly scalable global capacity make PAREXEL a leader in Pharmacovigilance outsourcing.

• ŸBroad and Scalable Models:

Whether you are looking to partner with us for case processing support, aggregate reporting, literature searching, medical assessment, or for an end-to-end product portfolio maintenance program, PAREXEL can tailor a solution to meet your unique needs.

• ŸGlobal Reach:  

We have the flexible capability and global reach to support large volumes of cases (currently handling ~600,000 cases each year) and can support affiliate models for many countries.

•  Industry-leading talent:

PAREXEL has a large team of global subject matter experts who are able to review systems, processes, documentation and technology in order to conduct a detailed gap analysis to identify process improvements, efficiencies, and adapt to changing regulatory requirements. Our experts 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
• EU QPPVs and Deputy EU QPPVs via our QPPV office.

Why juggle multiple providers and compromise efficiency? Let PAREXEL help you navigate through the complexity and more effectively achieve your goals.