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.
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