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Pharmacovigilance & Safety

The business of pharmacovigilance/drug safety and product safety in general (medical device vigilance, veterinary pharmacovigilance, cosmetovigilance) is a business more based on trust between client and vendor than any other business. This is why quality is the main focus of our pharmacovigilance and product safety services since 2003. We are proud of our client centric company culture highly sensitive to individual needs. We know that no two clients are alike and our philosophy is to shape our support in the form of the best symbiosis with your needs and structure. Out of our European global hubs we are offering cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety (device vigilance, vetvigilance, cosmetovigilance). In addition we have deep roots on local level in multiple countries which enables us to serve your local needs with no subcontracting.


During the eleven years of our product safety operations we have grown vigilance teams with targeted expertise to achieve stability and have combined it with lean management, short timelines of implementation of projects, and efficient pathways of communication. Based on experience we have implemented a specialized recruitment approach to attract the right talent for the right pharmacovigilance tasks globally and regionally. Language proficiency is tested extensively before recruitment. Our strength is in our people who posses strong academic background (pharmacists, medical doctors and life-science graduates), deep knowledge of legislation, coming mostly from large CROs with years of hands-on experience in pre- and post-approval projects for large and middle-size pharma as well as device manufacturers. Our Safety Officers posses long experience in AERS, ARISg and ARGUS. Year after year high retention rates secure continuity and are a basis for expansion.


Our local services are also continuously expanding covering presently 38 countries:

  • Albania
  • Austria
  • Bulgaria
  • Cyprus
  • Czech Republic
  • Estonia
  • FYR of Macedonia
  • Germany
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Malta
  • Moldova
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Slovenia
  • Turkey
  • Russia
  • Ukraine
  • Netherlands
  • Switzerland
  • MENA (Middle East and North Africa) region - Algeria, Egypt, Iraq, Iran, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Sudan, Syria, Tunisia and Yemen

 

To add to this unlike competition in all these countries we routinely apply quality review procedures on Local Literature Surveillance.


We add not only value to your system but build and sustain your image and reputation.

 

We offer a complete range of Pharmacovigilance/Drug Safety and Product Safety services, including:

  • Set up and implementation of Pharmacovigilance System, including writing/review of SOPs and preparation/maintenance of Pharmacovigilance System Master File (PSMF).
  • Collection, Assessment and Reporting of Adverse Events (AEs) originating from clinical trials or other organised data collection systems, spontaneous reports or literature.
  • In house ARISg database
  • Investigation and Assessment of Incidents and Near-Incidents.
  • International Literature Review and Local Literature review.
  • Provision of Qualified Person for Pharmacovigilance (QPPV) in Europe.
  • Provision of Local contact person for Pharmacovigilance/ Local QPPV in multiple countries.
  • Medical evaluation of Pharmacovigilance data and Signal Detection in order to carry out the Risk – Benefit assessment.
  • Writing and Submission to the Health Authorities of Clinical Safety Reports (such as Development Safety Update Reports (DSURs)) and Periodic Safety Update Reports (PSURs/PBREPs).
  • Operation of Risk Management System (RMS), including the writing of Risk Management Plan (RMP) and the preparation of material for Risk Minimisation Activities.
  • Audits on Pharmacovigilance and consulting Health Authority Inspections.
  • Registration to EudraVigilance and registration of products to XEVMPD.
  • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance
  • Training in Pharmacovigilance and Devicevigilance

 

Interest Form

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  • Interventional Trials - Phase I - IV
    Non Interventional Trials - Post Authorization Safety and Efficacy Studies
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  • We respect your privacy. We will not share, lease or sell your contact information.

     

ABOUT US

ZEINCRO is a leading contract research organization covering more than 21 countries in Europe, with a special focus in the region of Central and South Eastern Europe (Albania, Austria, Bulgaria, Cyprus, Czech Republic, Germany, Estonia, FYROM, Greece, Hungary, Latvia, Lithuania, Malta, Moldova, the Netherlands, Poland, Romania, Slovakia, Switzerland, Turkey and Ukraine).

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CONTACT US

  • Email:  info@zeincro.com

ZEINCRO : member of

European CRO Federation (EUCROF)

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