Pharma IT has an experienced team ready to assist you within all aspect of 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 etc. or assistance during implementation of a new solution in your team.”
We currently cover the following specialty areas:
- Local safety representative
- QPPV services – EU Qualified Person for Pharmacovigilance
- Assessment of Individual case safety report (ICSR)
- Risk Management Plans (RMPs) and aggregated reports
- Pharmacovigilance System Master File (PSMF)
Local safety representative
If your local Danish safety representative is absent, or you have a particularly busy period, our consultants are all experienced with the Danish pharmacovigilance legislation, and with safety training of sales staff, writing local SOPs, doing reconciliations and other tasks normally handled by your Danish safety representative. Please contact us if you have a shorter or longer term need for assistance.
QPPV services – EU Qualified Person for Pharmacovigilance
Due to medical expertise as well as numerous years of pharmacovigilance experience, our Danish-based consultants can act as EU-QPPV for your small pharmaceutical company and offer assistance in setting up the necessary procedures to support this role.
Assessment of Individual case safety report (ICSR)
The team is trained in data entry in the major used safety databases, 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.
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.
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
If you want to learn more about our services please contact Director of Pharmacovigilance, Ea Marie Holst at email@example.com / + 45 3022 2321