From screening to reporting, read through our insights into pharmacovigilance collaboration and workﬂows.
Most PV processes are a group activity. Each employee of a pharmacovigilance department has a special role in the team, and each member is equally important
Nobody looks forward to audits and inspections. But they are essential for the evolution of your PV department. They sniff out risks or imperfections in your workflow.
Depending on the client and substance, literature monitoring requires you to screen local databases. Each database differs from one another, and each has its own quirks and qualities.
PubMed is one of the biggest resources for literature monitoring, and it just keeps on growing. But the bigger the database, the tougher it is to pick up every relevant finding.
Now that you’ve identified and described all the risks that show up linked to the substance or medicine, it is time to put them into the context of their benefits.
Identifying risks is the most complicated and the most sensitive part of pharmacovigilance in general, including PSUR writing. Every risk has to be well-covered. There are layers upon layers to consider in risk assessment, and you need to approach it with special care. For some substances, they’re even harder to pin down than others.
The Literature section is one of the vital organs of PSURs. Most information you’ve accumulated plays a big part here. This is the section where you distill all the monitoring and screening you’ve done up to now and produce significant insights.
Literature monitoring is the backbone of all your PV reports. Their compliance depends on your skill to identify relevant literature. Many criteria determine a finding’s relevancy – so how can you recognize them efficiently?
Periodic Safety Update Reports require great precision and knowledge. A lot of organization and management goes into their composition. And you can achieve all that with good planning and preparation.
It would be an understatement to call Periodic Safety Update Report (PSUR) writing a challenge. Mounts of pressure lie on professionals who compose them. How can you keep excelling in such a strict and ever-changing regulatory environment?