
Pharmacovigilance involves the collection, monitoring, research and review of information obtained from doctors and patients relevant to side effects of medicinal products.
The Pharmacovigilance (PV) department within Centocor collects information regarding the use of Centocor products in order to continuously monitor the safety profile of the drugs. The PV team works in close collaboration with Global Regulatory Affairs for the compilation of the marketing authorization application dossier regarding the drug safety section of the dossier. Furthermore the PV team plays an important role in the notification of serious and unexpected adverse events to the national authorities and EMEA.
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