Pharmacovigilance

Pharma IT has an experienced team ready to assist you within pharmacovigilance. Our main competences lie within:

Individual case safety report (ICSR) handling:
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):
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.

Pharmacovigilance System Master File (PSMF) managing:
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.

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.

EU Qualified Person for Pharmacovigilance (EU-QPPV):
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.

Miscellaneous:
Additionally, our consultants have worked with major pharmaceutical companies and our competences cover:

  • Writing of PSURs/PBRERs/ACOs/PAERs/DSURs
  • Approving marketing material
  • Reviewing and providing input to clinical development plans, protocols, clinical trial reports and Investigator’s Brochures
  • Reviewing and providing input to company core data sheets as well as local labelling material

Serialisation

Pharma IT has one of the most experienced Serialisation teams in Denmark – and we are ready to help you with your Serialisation project. Our main competences lie within:

SAP ATTP

We have lead several ATTP implementations. Our roles at customer projects include SAP ATTP Track Lead and GS1/EPCIS Subject Matter Expert. We have assisted with e.g. Process Mapping and Process Guidelines, Packaging line integration to SAP ATTP, Tracelink integration, CMO Integration, 3PL Integration, Serial Number Management and Master Data Management.

Pharma IT has experience in setting up connection to the EU Hub.

Process and Regulatory consulting

We possess deep insight into serialisation requirements and the impact on pharmaceutical supply chain and we have spearheaded the Supply Chain side of serialisation projects incl. dialogue with 3PLs and CMOs.

Other Consulting Services

Furthermore, we have several Project Managers and Test & Compliance Managers with experience from Serialisation Projects. In addition, our network of subcontractors also includes production line engineers.

 

Please see our Serialisation Team here

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