Pharmacovigilance Services

Pharmacovigilance is an essential component of healthcare. It involves the collection, detection, assessment, understanding and prevention of adverse effects or any other drug-related problems that may occur after a pharmaceutical product has been released onto the market. By monitoring drugs on an ongoing basis and tracking their safety profiles over time, pharmacovigilance helps to ensure that medications are safe for use by patients while also providing important information about potential risks associated with certain drugs. This can help healthcare professionals make more informed decisions when prescribing medications to their patients in order to minimize risk and maximize benefit for all involved parties. SZReg Pharma provides a range of Pharmacovigilance services:

  • Risk management

  • Drug safety surveillance

  • Post-marketing activities

Our team of regulatory and safety writing experts support in authoring and compiling pharmacovigilance aggregate reports such as Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).