Establish/Oversight the PV system structure & performance.
Responsible for ICSRs (Individual Case Safety Report), PSURs (Periodic Safety Update Report), & Other Reports as requested.
Continuous PV evaluation post authorization.
Ensures request from authorities for info on benefit-risk is answered fully and promptly.
Deputy QPPV shall have sufficient authority to influence the performance of the quality system and PV activities to maintain, promote & improve compliance with legal requirements.
Safety data archiving.
Quality control of PV.
Training of the personnel on PV.
Submission of PSURs (Periodic safety update report ) upon request of M.O.H