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Pharmacovigilance & Safety

Our vigilance team is comprised of physicians, pharmacists and life sciences professionals. Our experts provide full vigilance support for products, including generics, innovator products, advanced therapies. Since 2003 we have delivered comprehensive, end-to-end high-quality pharmacovigilance services to our clients and we have also expanded our services to other vigilance categories such as medical device vigilance, veterinary pharmacovigilance and cosmetovigilance.


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.


From our strategically located European global hubs we are offering cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety (medical device vigilance, vetvigilance, cosmetovigilance). In addition, we have high skilled experts on local level in multiple countries which enables us to serve your local needs with no subcontracting.


During the second decade of our product safety operations we have developed 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. Our strength is in our people, who possess strong academic background, deep knowledge of legislation, years of hands-on experience in pre- and post-approval projects for large and middle-size pharma, device manufacturers etc. Year after year high retention rates secure continuity and are a basis for expansion.

 

Our local services are also continuously expanding. An indicative list of country coverage includes
(please contact us for more information):

  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Estonia
  • Greece
  • Hungary
  • Italy
  • Ireland
  • Israel
  • Latvia
  • Lithuania
  • Luxemburg
  • Malta
  • Netherlands
  • North Macedonia
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • South Africa
  • Turkey
  • Russia
  • UK
  • Ukraine
  • Algeria
  • Egypt
  • Iraq
  • Islamic republic of Iran
  • Jordan
  • Kuwait
  • Lebanon
  • Libya
  • Morocco
  • Oman
  • Palestine
  • Qatar
  • Saudi Arabia
  • Sudan
  • Syrian Arab republic
  • Tunisia 

 

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

 

We offer a complete range of vigilance services in Pharmacovigilance/Clinical Safety, Veterinary Pharmacovigilance, Medical Device Vigilance, Cosmetovigilance, including:


Post Marketing Pharmacovigilance Support

  • Set up and implementation of Pharmacovigilance System, including writing/review of SOPs and preparation/maintenance of Pharmacovigilance System Master File (PSMF).
  • Provision of Qualified Person for Pharmacovigilance (QPPV) in Europe, Turkey, Middle East and African Region
  • 24/7 Pharmacovigilance cover
  • Provision of Local contact person for Pharmacovigilance/ Local QPPV in multiple countries
  • International Literature Review and Local Literature Review.
  • ICSR handling – triage, assessment, MedDRA coding, processing –
  • Inhouse Safety Database
  • Electronic expedited reporting (e.g. through EudraVigilance)
  • Registering and maintenance of product information in XEVMPD
  • Safety signal detection and Management
  • Aggregate reports (PSUR/ PBRER/ PADERs)
  • Operation of Risk Management System (RMS), including the writing of Risk Management Plan (RMP) and the preparation of material for Risk Minimisation Activities
  • Direct Healthcare Professional Communication (DHPC) management
  • Controlled Distribution Activities as per Risk Management Plan
  • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance
  • Training
  • Regulatory Intelligence Services
  • Authority Website Monitoring


Clinical Trials Safety

  • Safety review/preparation of safety parts of clinical trial documents (including Protocol, SAP, CSR)
  • Preparation of Safety Monitoring/Management Plans
    for clinical trial conduct
  • Individual case safety report (ICSR) processing
    for Serious Adverse Events (SAEs)
  • Inhouse Safety Database
  • Expedited reporting (e.g. through EudraVigilance)
  • Aggregate report preparation and reporting (e.g. DSUR)
  • Training


Veterinary Pharmacovigilance

  • Set up and implementation of Pharmacovigilance System, including writing/review of SOPs
  • Creation and Maintenance of the Detailed Description of the Pharmacovigilance System (DDPS)
  • Provision of Qualified Person Responsible for Pharmacovigilance (24/7 cover)
  • Adverse event processing and reporting and efficient handling of communication of safety alerts (off-label, lack of efficacy, potential environmental problems)
  • Preparation/Writing/Submission of PSURs
  • Safety signal detection and Management
  • Screening of literature (both Global and Local) for identification of adverse events
  • Safety Data Exchange Agreements (SDEAs) set up and maintenance
  • EudraVigilance Set-up, Maintenance & registration
  • EudraVigilance Veterinary Medicinal Product Dictionary (EVVetMPD) maintenance
  • Training


Medical Device Vigilance

  • SOP creation and maintenance
  • Collection and follow-up of events
  • Investigation and assessment of Incidents and near-Incidents
  • Screening of literature for identification of events with medical devices
  • Reporting Incidents with Manufacturer’s Incident Report
  • Preparation and submission of Periodic Summary/Trend Reports
  • Implementation and reporting of Field Safety Corrective Action
  • Preparation, translation, distribution to receivers and submission to Health Authorities of Field Safety Notices
  • Training


Cosmetovigilance

  • SOP creation and maintenance
  • Assist Responsible Person within EU for safety related tasks
  • Preparing Safety Assessment Reports for placing cosmetic products on the market
  • Provide market surveillance system for Serious Undesirable Effects (SUEs).
  • Handling Undesirable effects/Serious Undesirable Effects (SUEs - SUE Form A)
  • Causality Assessment
  • Evaluation of trend or signal detection
  • Safety Data Exchange Agreements (SDEAs) set up and maintenance
  • Training


Training

  • Client staff training on pharmacovigilance or other product safety vigilance focused on the specific needs and tailor-made to the client.
  • Training on audits and inspections
  • Zeincro training programs on specific vigilance topics


Pharmacovigilance Auditing

Zeincro PV and Safety department have a dedicated, experienced and qualified team in order to provide services for assessing the performance and the quality of pharmacovigilance activities. Our services include:

  • Pre- audit and Pre-inspection preparation and support
  • PV system Auditing
  • Gap analysis on SOP and PV system
Interest Form

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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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