> Pharmacovigilance
Pharmacovigilance 2018-11-13T19:03:42+00:00
Drug Development

Pharmacovigilance

Viglya provides a broad spectrum of drug safety services tailored to the needs and requirements of our clients. Our experts have years of experience developing innovative and highly-customizable solutions for the drug safety management of both investigational drugs and marketed products. We help manage the safety of the client’s products with a regulatory-compliant and best-practices approach.

  • Establishment and maintenance of pharmacovigilance systems.
  • European Economic Area (EEA) Qualified Person for Pharmacovigilance (& deputy QPPV).
  • Local pharmacovigilance representative (eg, in Spain).
  • Direct interaction with local regulators on pharmacovigilance and regulatory matters.
  • Definition of pharmacovigilance and quality systems.
  • Guidance in defining an outsourcing strategy, qualification of service providers, oversight, and project management.
  • Guidance in identifying, assessing, and selecting a safety solution. Assistance with safety database validation (21CFR11) and implementation, and with safety data migration.
  • Assistance in identifying the best provider for Individual Case Safety Report (ICSR) processing.
  • Elaboration and testing of business continuity plans (eg, information technology system failure; disaster recovery; contingencies).
  • Assistance with selecting provider for (24h) medical information for scientific information.
  • Generation and maintenance of pharmacovigilance agreements.
  • Establishment of clear communication channels and methods with partners.
  • Compilation, medical review, and submission of PSURs, addenda, and summary bridging reports.
  • Elaboration of RMP/REMS.
  • Assistance in defining pharmacovigilance actions, risk minimization and risk prevention strategies.
  • Assistance with defining and implementing safety monitoring activities and epidemiology strategies during all phases of drug development, peri-approval stage, and product commercialization.
  • Support in defining and implementing safety signal detection, investigation, and evaluation activities for marketed products.
  • Assistance with selecting a CRO for the conduct of epidemiology and post-authorization safety studies.
  • Conduct of searches via databases e.g. Medline and Embase.
    – Screening of abstracts/articles for the identification of potential ICSRs (including Events of Special Interest)
    – Screening of abstracts/articles for identification of potential new and significant safety findings for inclusion in PSURs and ongoing Safety Signal Detection Activities.
  • EMA Medical Literature Monitoring (MLM) daily review .
  • Targeted Literature Screening for Safety Assessment And Benefit Risk Analysis.
  • Local literature searches in journals not indexed in international databases.
  • EudraVigilance signal detection, complying with the new regulatory requirements. Competency in the EVDAS interface and eRMR use for signal screening.
  • Support and signal management throughout the signal full lifecycle.
  • Scientific (medical) literature screening.
  • Monitoring of publications on safety issued by global regulatory agencies (EMA, FDA, WHO, PMDA, NCAs, etc.)
  • Training on signal detection activities.
Find out why Viglya is your strategic partner in drug development.Read more