Global Pharmacovigilance

We provide this service as part of our Pharmacovigilance system and for medical writing services, conducting global and local literature screening in any area of interest. We can also conduct a search of a specific area, and write up a report with all the necessary information.

Literature screening as part of our PV system

This consists of searching scientific literature for implicit or explicit material which the author associates with a specific adverse event, or for other safety information relating to the products being monitored.

Medical and scientific journals are scanned for data relating to:

  • Individual Case Safety Reports (ICSRs) including requested and non-requested reports
  • Published studies containing new safety findings
  • Publications from congresses or abstracts from meetings
  • Publications from registries, studies or Drug Information Centres, only if the author associates a specific adverse event with one of the products or with one with the same International Non-proprietary Name (INN).

Our Search process

International Literature Screening

  • We will screen medical and scientific literature from all over the world with a periodic review of our database.
  • We include in our search criteria, areas of interest as adverse reactions to medicines, interactions...

National /Local Literature Screening

  • This consists of a periodic review of local medical and scientific literature, depending on the country or region being analysed. The data are obtained from journals or publications not indexed in our database.
  • Journals shall be selected taking into account the list of substances to be reviewed and the previously agreed upon countries or regions.

Process for regular weekly literature searches

During the process we perform some activities as obtain copies of relevant articles, review of medical and scientific literature for defined products…

Quality Control

The Deputy EU QPPV is responsible for ensuring that weekly literatures searches and verifications are conducted and processed. He/she is also responsible for the quality control in procuring literature providers for local searches.

The EU QPPV is responsible for approving the validation report on the updated consultation.

Literature Screening for other purposes

Our literature review services go beyond those for PV purposes. If a client requires a literature search relating to a specific matter, we can offer an optimal solution in line with specific requirements thanks to our technical resources and know-how.

This process would begin by determining the search criteria to ascertain the client’s requirements, and then we would analyse these requests and offer a proposal.

If the client agrees with the solution proposed, we would conduct a test, validate it and deliver the results to see if requirements were met. Our quality control would be applied throughout the entire process, as all our deliverables are subject to our stringent quality standards.

European Countries

We provide local literature screening for the following countries in Europe: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom.

CIS Countries

We provide local literature screening for the following CIS countries: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Russia, Tajikistan, Turkmenistan and Uzbekistan.

Other countries

We can provide local literature screening for other countries not mentioned above but just upon request.

Business Cases

  • Case Study detail

    Local Pharmacovigilance Management

    Global Pharma Company, United States
  • Case Study detail

    Full outsourced EU Pharmacovigilance system

    Leading Generic company, North America

Contact Us

If you want to dicuss how you can be safe in our hands, please contact us for a consultation.

Telephone: +353 125 44033

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