Regulatory Affairs & Warehouse Pharmacist - #25509
About Zahrawi Group
Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.
job BriefResponsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time. They are also responsible for the preparation of the pre- and final perm
Policies & Procedures:
- Adhere to all Zahrawi Policies & Procedures as applicable.
- Ensure that Zahrawi’s products comply with the regulations of the MOH.
- Keep up to date with the latest changes in regulatory legislation and guidelines.
- Liaise and negotiate with regulatory authority to ensure a smooth registration process.
Product Classification & Registration:
- Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
- Prepare all required documents to be submitted for Product Classification under MOH.
- Prepare all required documents to be submitted for Manufacturing Site registration under MOH.
- Prepare and apply for the pre-permit document as per the MOH guidelines and verify the items being imported and the documents required.
- Communicate with the existing and new suppliers regarding MOH importation rules and policies.
- Upload on the MOH importation system any new classifications or registration certificates.
- Prepare any documentation needed for internal and external audits.
- File all documents in the corresponding files to ensure all are available and are correct.
- Evaluate the suggestions after the audit and implement them when possible.
- Responsible for Pharmacovigilance related work and assigned as deputy QPPV.
- Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer’s comments.
- Conduct monthly PV activities to keep full compliance with the regulations.
- Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.
Medical Devices FSN/FSA Vigilance system:
- Report the received FSN/FSA to the health Authority and keep align with the reporting timelines.
- Keep tracking for the reported cases and the health Authority requirements to ensure fulfillment.
- Keep updated with the new regulations related to the local vigilance system and report them to the manager
- Education: Bachelors Degree
- Additional details:
- Candidates must be based in the UAE and should be willing to move to company visa
- Candidates must have a valid MOH license
- Experience: 2 - 4 years of experience.
- Job Specific Skills: Require a good knowledge in Pharmacist, Regulatory Affairs, Importation Permits
Location: UAE - Dubai
Job Type: FULLTIME
Job Posting Date: 18-09-2023
Division/Department: Warehouse Operation and Distribution