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Pharmacovigilance
Pharmacovigilance is a procedure-based method of monitoring events that take place in patients who are using a particular drug. The Weinberg Group helps clients to develop pharmacovigilance programs where data are collected and interpreted, and any adverse affects are reported to the FDA on a regular basis. This includes the following key tasks:
- Design and analyze post-marketing surveillance studies, programs and registries
- Detect and evaluate signals
- Identify and assess risk
- Provide risk management strategy and program support
- Develop risk minimization action plans
- Perform routine surveillance and analysis of scientific and clinical literature
- Deliver technical and regulatory support for unexpected safety issues and products in crisis
- Assist in developing product safety update reports
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