Biometrics
Pharmacovigilance & Safety Monitoring
NoyMed’s professional team of Pharmacovigilance specialists has 10+ years of expertise and valuable experience working with the biggest names in the pharmaceutical industry. Our team consists of highly experienced doctors and physicians.
Pharmacovigilance
- Individual Case Safety Reports (ICSR)
- Safety Surveillance and Risk Management/Signal Management Process
- Aggregate Reports
- Qualified Person for Pharmacovigilance (QPPV)
ICSR
- Case intake
- Case triaging
- Case processing
- Events coding
- Quality control
- Medical review
- Submission to the regulatory bodies
Safety Surveillance and Risk Management / Signal Management Process
- Monitoring global and local indexed and non-indexed journals, and data mining
- Signal detection
- Signal validation
- Signal assessment and evaluation
- Signal confirmation
- Risk minimization measures: risk management plan/risk evaluation and mitigation strategies
Aggregate reports
- Periodic Safety Update Reports
- Periodic Benefit Risk Evaluation Reports
- Periodic Adverse Drug Experience Reports
- Ad-hoc Reports and Health Authority Queries
QPPV
- Establishment and maintenance of the marketing authorization holder’s pharmacovigilance system (PSMF)
- Overview of drug safety profiles and emerging safety concerns
- Awareness of conditions relating to safety of the products
- Awareness of risk minimization measures
- Review and sign-off of protocols of post-authorization safety studies
- Submission of PV-related documents in accordance with the legal requirements
- Ensuring a full response to request from the competent authorities (CA)
- Providing input into the preparation of regulatory action in response to emerging safety concerns
- Acting as a single PV contact point for the CA on a 24-hour basis and also as a contact point for PV inspections.
Safety Monitoring
- Medical monitoring plan preparation
- Medical support for investigator sites and project teams
- Responding to subject eligibility and withdrawal questions
- Medical review of Serious Adverse Events (SAE)
- Review of safety parameters and alert reports
- Medical review of coding
- Medical review of clinical study protocols and reports
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Pharmacovigilance
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