Drug Safety & Pharmacovigilance

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 eah@pharmait.dk / + 45 3022 2321

Meet the Drug Safety & Pharmacovigilance team:

Pharmacovigilance Consultant, Quality & Compliance Consultant
Maria Skou Andersen

Cand.pharm with five years of pharmacovigilance experience including strong knowledge of MedDRA coding. Successful completion of EMA’s XEVMPD knowledge evaluation. Capable of providing guidance and training to new EVWEB users for them to comply with the reporting guidelines. Capable of creating and updating XEVMPD records. Experienced with databases such as Argus, Empirica and QlikView. Currently studying Master of Pharmacovigilance at the University of Hertfordshire, UK. EDMS system expert with advanced Veeva system administrator certification and experience with Veeva implementation. Experienced with compliance tasks such as system validation within the drug safety area.

Certified Veeva Vault Administrator, Veeva
Pharmacovigilance Consultant
Mie Altermann Sørensen

Pharmacovigilance professional with 6 years of experience from the pharmaceutical industry. Experience from working in both headquarter and affiliate. Includes: Signal detection, literature monitoring, pharmacovigilance training, individual case safety report processing, including coding and narrative writing, scientific evaluation and reporting. Medical information activities; writing medical responses to health care professionals, direct costumer contact. Studying Master of Medicines Regulatory Affairs. 

Pharmacovigilance Consultant
Louise Søgaard Nielsen

10 years of experience as a pharmacovigilance professional. Experience with all aspects of pharmacovigilance including; ICSR case processing and reporting, Signal Detection, PSUR and DSUR writing and submission; Risk Management Plans and maintaining and building quality management systemst a larger pharmaceutical company in the Copenhagen area.

Pharmacovigilance Consultant
Kristine Kornøe

Experienced in clinical and postmarketing safety after working 6 years as a Drug Safety Advisor in a large danish HQ. Experience include: Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training, E2B reporting, ICSR case processing and reporting.

Partner, Drug Development Consulting
Ea Marie Holst
eah@pharmait.dk
+ 45 30 22 23 21

Pharmacovigilance professional with more than 14 years of experience working in both headquarters and affiliates within; Signal Detection, Risk Management Plans, PSUR/PBRER and DSUR writing; maintaining and building quality management systems; pharmacovigilance training, E2B reporting and testing, handling of individual cases. Trained user of several adverse event databases.