Pharma IT has an experienced team ready to assist you within safety and pharmacovigilance. Whether you need urgent help during maternity cover, illness ect, or looking for more permanent outsourcing solutions as an entire process such as case handling, aggregrate report writing, QPPV-services, PV-audits or assistance during implementation of a new solution in your team.”
We currently cover the following specialty areas:
- EU QPPV and Deputy QPPV – EU Qualified Person for Pharmacovigilance
- Local QPPV/safety representative
- PV Audits and assistance with Inspections
- Drug Safety Operations – Processing of Individual case safety report (ICSR)
- Risk Management Plans (RMPs) and aggregated reports
- Scientific Literature Monitoring
- Pharmacovigilance System Master File (PSMF) and Standard Operating Procedures
- Optimizing and supporting daily processes via IT
EU QPPV and Deputy QPPV – EU Qualified Person for Pharmacovigilance
Our consultants can act as EU-QPPV/deputy QPPV for your company and offer assistance in setting up the necessary procedures to support this role. Before commencing the role as EU-QPPV we will perform a PV audit, and if any discrepancies from an inspection-ready state are found we want to ensure that these are handled and the QPPV-services can begin.
Local QPPV/safety representative
If your local safety representative is absent, or you have a particularly busy period, our consultants are all experienced with the pharmacovigilance legislation, and with safety training of sales staff, writing local SOPs, doing reconciliations and other tasks normally handled by your local safety representative. Please contact us if you have a shorter or longer term need for assistance.
PV Audits and assistance with Inspections
If you are notified that you will be inspected by any authority, Pharma IT is ready to assist you with ensuring your process is inspection-ready. We also perform PV audits as an external partner working together with your QA-team or fully independent, depending on your set-up. Please note, that regulatory authorities expect regular PV audits, and that these are conducted by external experts.
Drug Satety Operations – Processing of Individual case safety report (ICSR)
The team is trained in data entry in the major used safety databases such as Argus and ARISg, and our consultants can handle every step from book-in, through data entry, quality control, safety review, medical review and distribution/reporting to authorities and partners. Pharma IT can also provide a safety database via the Pharma IT cloud.
Risk Management Plans (RMPs) and aggregated reports
With the release of the EU GVP Module V in March 2017, pharmaceutical companies need to adapt to a new standard of reporting. Our consultants are experienced in the old and the new format and can help you transfer into the new format; and additionally we are ready to help you with the content as well due to our experience across many different therapeutic areas. We are all very experienced writing other aggregated reports such as PSUR, DSUR, ACO and perform the benefit/risk assessment necessary for concluding on the safety of your product.
Scientific Literature Monitoring
Although EMA has started screening worldwide literature for some substances, the pharmaceutical companies are still expected to perform their own literature review. Pharma IT can assist you with screening of literature, both locally and globally.
Pharmacovigilance System Master File (PSMF)
Our consultants are very experienced in maintaining and building the PSMF for small to large size pharmaceutical companies. Often the demands of the PSMF needs to be reviewed and complied with before the first marketing authorization is granted in the EU, so please contact us, if you need strategic advice on how to set-up your system most efficiently and compliant. In addition to the business consulting, Pharma IT is also able to assist you with an electronic solution to tailor and implement to maintain the PSMF via the Pharma IT cloud.
Optimizing and supporting daily processes via IT
Based on our extensive knowledge about safety and pharmacovigilance processes Pharma IT can optimizing and support your daily processes via the Pharma IT cloud.
If you want to learn more about our services please contact Director of Pharmacovigilance, Ea Marie Holst / + 45 3022 2321