The team handles the following activities.
- Processing of Individual Case Safety Reports (ICSRs), investigation of reports of serious adverse events (SAEs), and investigation of reports of suspected unexpected serious adverse reactions (SUSARs) from receipt to submission.
- Formatting: Data entry cases can be managed in a database or by taking any approach specific to the client’s document (receipt of XML in R3 format)
- Writing of the safety management plan
- EudraVigilance ICSR download and medical-literature-monitoring search
- Medicines and Healthcare products Regulatory Agency (MHRA) ICSR download
- Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)
- Off-label-use-report writing (requirement in France)
PLG has various tools that it customizes during a project’s implementation phases, thereby ensuring that the final tools always meet relevant regulatory requirements (databases, forms, etc.)
PLG’s teams also help clients with the selection, implementation, and validation of artificial intelligence solutions to enhance and streamline the case management process.
The team has more than 40 employees based in different countries (France, Germany, Italy, Mauritius, Romania, Tunisia, and others) who are vigilance associates, data officers, case specialists, and medical advisers.
Our data officers are scientists with specific training in vigilance processes, and our case specialists either are pharmacists or have graduate science degrees in life sciences fields.
My name is Nicola Brown. I am the activity manager for the case management line of business, and I have been with PLG for five years.
I enjoy being part of a dynamic, fast-growing company, where quality is paramount and no two days are the same.
My name is Ons Bouhlel. I have been with PLG since the acquisition of Axpharma, which I joined in 2018. I am the team leader of the case specialist team in Tunisia.
Our profession requires high levels of expertise, and it’s given me a great opportunity to grow professionally surrounded by a dynamic team. I look forward to continuing to expand my professional expertise in the years ahead.
Clinical trials during the past 3 years
Total volume of cases processed including, initial phases and follow-up during the past 3 years