Sympto’s blog
From screening to reporting, read through our insights into pharmacovigilance collaboration and workflows.
PV operations: Is e-mail the only way to organize your team communication?
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
PV Audits and Inspections: 5 pressure points to watch out for
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.
How to build the perfect search strategy: Local databases
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.
How to build the perfect search strategy: PubMed
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.
The 9 crucial steps of weighing risks and benefits in PSURs
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.
Risk identification in PSUR
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.
Writing the Literature section in PSUR
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.
Relevancy in literature monitoring
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?
Getting started with PSUR writing
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.
The profile of a PSUR writer
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?