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 covering diverse therapeutic areas such as oncology, hematology, transfusion medicine, gastroenterology, infectious diseases, traumatology, orthopedics, surgery, sexology, dentistry, radiology, pulmonology, cardiology, and more.
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)
- Assessment of SAE reports
- Review of safety parameters and alert reports
- Medical review of coding
- Medical review of clinical study protocols and reports