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?
And how often do you check the GVP while composing a PSUR?
You are alert to the constant adjustments and changes in the appropriate regulations and requests. You weigh and analyze complex information to make the right call about a substance. As a PSUR writer, you constantly keep up and perfect yourself on numerous fronts:
Pharmaceutical
To do the job correctly, you have to understand a given medicinal product’s safety profile. What does a specific side-effect imply and what is its frequency? What are the substance’s benefits and how do they scale to its risks?
Sometimes it can be crucial to compare the effects of a single substance to the effects of others in its drug class. Differences between molecules can boil down to mere nuances – and it is on you to discern which nuance is lighter.
Management
Organizing your time and tasks also helps to increase the workflow of your whole work department, as applicable. If each link in the report writing chain is punctual and smooth, you can avoid stress or possible risks.
That’s why Sympto® functions as a project management tool, too. Every important date and deadline is neatly listed on your Dashboard. Here, you can check all your priorities. Also, the notification system keeps track of all your tasks and actions. Sympto® makes sure you don’t miss anything. Also, Sympto® allows you to effortlessly retrieve summary tabulation and line listing data needed for your PSUR writing.
Insight & expression
And to be able to make these decisions, you have to possess good insight. Understand the core of an information, and express this core point in a clear and coherent manner.
In other words, get right to the pith of an article, and then analyze and recount it in the most economic way. Clear and on-point writing may seem easy at first, but it’s a feat you acquire through practice and experience.
Regulatory
With shifts in European legislation, aggregate report writing has become a multidisciplinary task. Aside from sound knowledge of pharmaceuticals, a PSUR writer has to be up-to-date with stringent laws and regulations.
The legal frameworks around you are a dynamic environment, one that always keeps you on your feet. Checking EMA’s or FDA’s page for the latest news should already be a regular part of your work routine.
Decision making
The most sensitive points of a PSUR rely on your own knowledge and reasoning. The complexity and novelty of a substance can blur lines between what is important and what is relevant.
Good decision making is most needed when it comes to identifying risks or discerning which literature to include in your report. A regulatory professional has to show sharp critical judgment in these matters.
It’s a delicate job, deciding what matters are more pressing than others and what information is vital. Sometimes, it’s best to consult your coworkers if you work in a team. Share insights and experience. In Sympto®, you can easily do that through comments.
The big picture
Last, but not least, PSUR writing requires good foresight. You can’t view a report as an isolated instance. Following through with regulations requires a broader view of planning and assessment.
When thinking about your current report, you have to take into account all previous and future steps in safety monitoring. Otherwise, comparing interval data to accumulated data would lack depth and bigger implications.
Research and educate yourself from numerous sources to hone the skills needed for PSUR writing. When in doubt, just go back to the GVP and SmPC.
Seeing all these responsibilities listed like this can seem intimidating. Is it possible for us to hold every string in our hands and neatly tie them together? Can we keep up with increasing concerns and competition, without breaking a sweat?
You have to control numerous details, which is a challenge even for seasoned professionals. This is why we compiled a series of articles that tackle the more delicate aspects of PSUR writing.
But before we address more formidable issues, let’s run through the fundamental advice anyone in the field of pharmacovigilance or PV associated medical writing should live by. In the end, you always have to lay solid foundations if you want the end result to have quality.
General tips
Get to know your SmPC
If you don’t possess one already, you can, for the most part, find the substance’s SmPC on the web page of your competent local authority. Check if you are able to get a copy.
As you read through it, you can leave notes on Sympto® next to entries relevant to a certain part of the SmPC. It’s a great way to leave reminders for yourself, so you never lose sight of what’s important.
Google/PubMed
Google and PubMed are not the most reliable medical advisors, but they can help you build on the knowledge you’ve gained from the SmPC.
If you look through search results critically, they can advance your insight and get you more acquainted with a substance. They can also point you in a direction that needs further research or give you a heads up of the most common characteristics you’ll encounter in literature.
Keep a copy of GVP at hand
To write compliant PSURs, you have to be well-versed in regulatory requirements and guidelines. The GVP Module VII is a long and detailed document that can be hard to digest. Keep an open PDF or print it out. As you go on, underline parts you’ve checked and finished. It’s the best way to learn PSUR sections and check up on your work.
Read old PSURs
If you have access to old, already approved PSURs, take the opportunity to read them. They’re a window into what others have found relevant, how they summed up the main points of studies, and the way they weighed risks.
It’s easier to develop your own judgement by dissecting the judgements of others. However, keep in mind that there will be differences in sections from one PSUR to another, so it’s not wise to depend solely on them.
Now that we’ve gone through all the steps of your warm-up, it’s time to get started with PSUR writing. Find out how in our next article.
Feel free to ask more about this topic.
And if you want to know more about Sympto®, we invite you to
© 2018 Marti Farm Ltd. All rights reserved.
No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of Marti Farm.
The information contained herein may be changed without prior notice. Some software products marketed by Marti Farm contain proprietary software components of other software vendors.
National product specifications may vary.
These materials are provided by Marti Farm for informational purposes only, without representation or warranty of any kind, and Marti Farm shall not be liable for errors or omissions with respect to the materials. The only warranties for Marti Farm products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an additional warranty.
In particular, Marti Farm have no obligation to pursue any course of business outlined in this document or any related presentation, or to develop or release any functionality mentioned therein. This document, or any related presentation, and Marti Farm’s strategy and possible future developments, products, and/or platform directions and functionality are all subject to change and may be changed by Marti Farm at any time for any reason without notice. The information in this document is not a commitment, promise, or legal obligation to deliver any material, code, or functionality. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forward-looking statements, and they should not be relied upon in making purchasing decisions.
Marti Farm products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of Marti Farm in Croatia and other countries. All other product and service names mentioned are the trademarks of their respective companies.