Drug Safety & Pharmacovigilance

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

Meet the Drug Safety & Pharmacovigilance team:

Senior Pharmacovigilance & Device Consultant
Sukhjit Gill

Senior Pharmacovigilance & Device Consultant holding 12 years of experience from several pharmaceutical companies and additionally 3 years of experience within the medical device industry. She has experience working with various pharmacovigilance development and post-market surveillance tasks such as DSUR and PSUR/PBRER writing, setting up AE/SAE flows for clinical trials as well as reconciliation and MedDRA coding, SOP writing, Pharmacovigilance training, Literature monitoring, ICSR case processing and reporting, Device vigilance complaint handling, evaluation of serious incidents, reporting of MIRs and communicating with Regulatory Authorities/Notified Body and execution of Recalls/FSCA and FSN. Has been part of implementing the new MDR regulation within device vigilance

Clinical Evaluation for Medical Devices in Europe, Medical Devices: Regulation and Life Cycle Management, MedDRA Safety Data Analysis and SMQs
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.