Effective Pharmacovigilance

Effective Pharmacovigilance      (PVIG)   (3)

Objectives

To be able to effectively manage all the Pharmacovigilance requirements set out in the SAHPRA Document (May 2022) Pharmacovigilance Systems  

Outcomes

• To be aware and able to implement all the routine PV activities listed in SAHPRA document e.g. submit ADR PSUR/PBRER
• To ensure all PV staff comply with SAHPRA requirements e.g. qualifications, residence, training, implementing quality system  
• To be able to set up / maintain the company’s Pharmacovigilance Site Master File
• To be able to set up / maintain SOP’s for all Pharmacovigilance activities 
• To have all documentation etc in place for a successful SAHPRA PV inspection