Pharmacovigilance (IPV or PhV), also known as Drug safery. Is the pharmacovigilance science Relating to the collection, detection, assessment, Monitoring and prevention of adverse effects with Pharmaceutical products. The etymological roots for the word “pharmacovigilance”” Are: pharmakon (greek for drug) and vigilare (Latin for the keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy.
We provide service to meet regulatory requirements for Aggregate reporting for all stages of the life cycle Products, including Preodic Safety Update Reports (PBRER), Risk management Plan (RMP) for European Union Region and Periodic Adverse Drug Experience Reports (PADERs) for United Stages Rgion.
We developing and monitoring risk management Plans and risk evalution and mitigation strategies, And performing benefit-risk analysis.
We provide service to assess safety data and identify new Safety signals through screening, data mining and frequency For potential signals using qualitative and Quantitative including statistical signal detection methods At monthly, quarterly, and/or annual frequency.
We perform and generate signal detection, signal validation And prioritization, signal evolution reports and track signals For products to meet the regulatory requirement.
We create a search strategy and perform global and Local literature review to identified individual Case Safety Reports (ICSR) [Valid and invalid (non-valid)], And relevant safety information for aggregate reporting/signal detection.
Creating global labeling document including Company Core Date Sheet (CCDS), Summary of Product Characteristics (SmPC), and Package Insert (PI) Updates of existing labels including CCDS, SmPC and PI Prepare a response to Health Authority query or recommendations (e.g. PRAC, CMDh, CHMP, Etc)