• Establish and maintain the Market Authorisation Holder’s (MAH) Pharmacovigilance System

 

• EEA-QPPV and local QPPV (in Italy) 

 

• Receiving and processing safety data from the public, from health professionals, competent authorities, clinical trials and literature sources, amongst others

 

• Provide medical review of case reports

 

• Expedited reporting of adverse drug reactions

 

• Signal Detection

 

• Global and local literature screening and review

 

• Periodic Safety Reporting (PSURs/PBRERs; DSURs; RMPs)

 

• Training in pharmacovigilance

 

• Preparation of PSMF

 

• Creation of Safety Data Exchange Agreements (SDEAs)