A Patient Safety Responsible offering 1 year and 9 months of experience, covering MEA region. I've been exposed by two inspection by SFDA authority at different MAH, 1 audit on regional level. I'm seeking a higher challenges that would provide me the best practice at PV area, and increase my knowledge, communication on managerial level.
I've been handling the below tasks on a local, and regional level
-ICSR Management.
-Literature Screening.
-Reconciliation
-On boarding PV Training
-Annual refreshment .
-Establish and maintain effective SOP's.
-Keep up to date local drug safety legislation and update global team on regulation update.
-Maintain the list of product and maintain with regulatory team.
-Ensure of monitoring of organized data collection related to PV aspect.
-RMP tracking for submissions in relevant country.
-PSURs Submission
-PVA
Locally
-Signal assessment
-PSSF (Gap analysis)
-Create PSSF.
-ICSRs management.
SFDA Pharmacovigilance System Explained.
Feb-2021
SFDA Pharmacovigilance System Advance
Oct-2021