RENEWED: 18 hours ago
REF 1855311
21.07.2025 | Abu Dhabi | full time
- General
- Location: Abu Dhabi
- Occupancy: full time
- Description
- Day to day management of the PV Team.
Ongoing monitoring of the safety profile of our clients medicinal products and continuous overall safety evaluation during the post-authorisation period.
Oversight of Individual Case Safety Reports (ICSRs), Standards Operating Procedures (SOPs), authoring aggregate reports (PSURs and PADERs) and Safety Data Exchange Agreements (SDEAs).
PV SME for Risk Management Plans (RMP), Post Authorization Safety Study (PASS) protocols, Risk Minimisation Strategies, effectiveness of follow-up measures, post-marketing commitment and e-transmissions to competent authorities.
Audit/inspection readiness for the PV audits, ensuring successful audit/inspection outcomes and ensuring findings are appropriately addressed and closed timely.
Ensuring the 5-year audit plan for pharmacovigilance is executed as planned, maintained on an ongoing basis and ensuring the pharmacovigilance system is fully audited on a rolling 5-year basis.
Author or review and sign off aggregate reports (PADERs and PSURs), Risk Management Plans particularly if they relate to drug safety, to assure that quality is maintained and that benefit/risk information is accurate and not misleading.
Ensure departmental compliance with EU, US, Canadian and other relevant global pharmacovigilance regulations
- Requirements
- Experience: 3 years
- Bachelor degree
- CV
- Provisions
- Salary: to be discussed
- Employment visa provided
- Transportation provided
- Housing provided
- Medical insurance provided
- Publisher
- direct employer
- 51 - 200 employees