Haya Bin Omar
Riyadh ,Saudi Arabia
Summary
A passionate patient safety senior Specialist with 5 years’ experience in Pharmacovigilance in Saudi Arabia and cross MENA region. Proven expertise in PV systems, SFDA inspections, and audits for multiple MAHs.
Eager to contribute my experience and background to be accountable for leading and maintain the PV system with alignment of the global and local requirements.
Overview
4
4
years of professional experience
1
1
Certification
Work history
Patient Safety Senior Specialist
Sandoz
Riyadh
07.2023 - Current
1-Regulatory intelligence.
2-PSMF/ PSSF gap assessment.
3-PVA Management.
4-RMP/ DHPC local Adaption (aRMM Activities).
5-Weekly literatures screening.
6-Managing PV Activities for Patient Support program/ Social media pages.
7- Signals/Safety alert management.
8-Comprehensive archiving for PV system.
9-Reconciliation management.
10-PV (on-boarding/Refreshment)training.
11-ICSRs management.
12-PSURs management.
13-Local SOP’s implementation.
14-Vendor oversight management.
15-PV management activities for clinical trials.
Patient Safety Saudi Arabia -Senior Manager
Mundipharma
Riyadh
05.2021 - 06.2023
Regional experience :
-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.
-PSURs Submission
-PVA
-PSSF (Gap analysis)
Education
Princess Norah University
Skills
- Strong communicator across all organizational levels, composed under pressure, and adept at managing time effectively Proficient in Microsoft PowerPoint, Excel, and Word Fluent in Arabic and English, with high professional ethics, integrity, and strong self-discipline
Certification
SFDA Pharmacovigilance System Explained.
Feb-2021
SFDA Pharmacovigilance System Advance
Oct-2021
Drug Safety Congress Europe
Sep-2024
Timeline
Patient Safety Senior Specialist
Sandoz
07.2023 - Current
Patient Safety Saudi Arabia -Senior Manager
Mundipharma
05.2021 - 06.2023
Princess Norah University
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