Regulatory Affairs Executive/Officer & Warehouse Pharmacist - (314)
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 BriefThe incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time.
Policies & Procedures:
- Adhere to all Zahrawi Policies & Procedures as applicable.
- Ensure that Zahrawi’s products comply with the regulations of the NHRA.
- 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.
- Provide advice about regulations to customers/suppliers.
- Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.
- Prepare and apply for the permit document as per the NHRA guidelines and verify the items being imported and the documents required.
- Apply for the NHRA regulated products permits on the NHRA website as per the specified guidelines.
- Register and submit the permits for SCE when required.
- Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
- Prepare daily report regarding the rejections/ delays for NHRA importation permits and reasons related to that.
Importation Rules & Regulations:
- Communicate with the existing and new suppliers regarding NHRA importation rules and policies.
- Upload on the NHRA importation system any new classifications or registration certificates.
- Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
- Report any deviation from NHRA guidelines of imported shipments and take the corrective and preventive action accordingly.
- Review on a regular basis the NHRA importation process of distribution agreements.
- Ensure that the NHRA license is renewed before expiry date to avoid importation disturbance.
- Segregate the imported products as per HS code in coordination with logistic team and confirm if products are NHRA regulated or not.
- Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.
- Act as the LRPPV (Local Responsible Person for Pharmacovigilance).
- Perform regulatory intelligence by screening the NHRA websites on a weekly basis.
- Screen all scientific and medical literature to stay up to date with the latest regulations.
- Comply with local regulatory requirements for reporting adverse drug reactions and submission of safety reports.
- Responsible for all Pharmacovigilance related work and assigned as the LRPPV (Local Responsible Person for Pharmacovigilance)
- Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer’s comments.
- Fill the Council for International Organizations of Medical Sciences (CIOMS) forms with all the information collected from the ADRs.
- Send all CIOMS forms to the Manufacturers and the relevant authorities.
- Manage the Pharmacovigilance process of Zahrawi by and prepare all SOPs, product safety reviews and literature reviews when needed.
- Maintain a high level of standard to ensure that all work is moving smoothly and that there are no delays.
- Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.
- Prepare all Registration and Pharmacovigilance forms and communicating the same to the Suppliers and stakeholders.
- Provide trainings to all internal divisions on the current Pharmacovigilance Policies & Procedures.
Individual Case Study Reports (ICSRs):
- Report any spontaneous Individual Case Study Reports (ICSRs) to the Supplier and the Health Authority.
- Maintain a soft and hard copy of all ICSRs for the future.
- Track and follow up with all active ICSR reconciliation with the respective authorities.
- Report all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities.
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 NHRA.
- Prepare all required documents to be submitted for Manufacturing Site registration under NHRA.
- Prepare all the Dossiers to be submitted to NHRA for product registration.
- Collect all necessary documents from Supplier to submit for Health Authorities.
- Monitor all Cold Products from point of receiving until delivery of products to customers along with Data Logger results within the set temperature limits.
- Examine the packing of goods from the cold storage and monitor the Data Logger Report to ensure consistency.
- Check the quality of the vehicles, warehouse cleanliness, temperature control mechanism, storage conditions and validity of goods on shelves on a regular basis.
- Ensure all Zahrawi Cold Vans/Delivery Vehicles, Data Loggers are calibrated regularly and update the temperature mapping of the Warehouse.
- Ensure all required licenses and registrations as well as calibration renewals are updated before their expiry dates.
- Review all technical and quality agreements with suppliers and customers on a regular basis.
Warehouse Quality Check:
- Ensure that the Warehouse & Service Room are kept clean and organized.
- Ensure that the temperature control mechanism and hygiene standards are maintained in the Warehouse.
- Ensure a quick and accurate release of shipments from NHRA to avoid any delays in transporting the products to the customer.
- Ensure that all stock areas are segregated properly into: Dispatching, Receiving, Returns, Hold and Expired and that no mix-up could happen at any time.
Product Quality Check:
- Ensure that a sample of each batch of products is secured from the WH Assistants and provide the samples along with a progress report and supplier invoice to the Warehouse Operation, QA & RA Manager for NHRA release approval.
- Check all shipments leaving the Warehouse are sealed and packed properly and if the vehicle is fit for transporting the products.
- Compile all Quality Inspection Forms prepared by the Sr. Driver & Fleet Coordinator and prepare a monthly report.
- Generate a discrepancy report to the Warehouse Operation, QA & RA Manager for MOH release approval for any late findings (excess, damaged or expired goods) in the shipment.
- 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.
- Develop a professional relationship with the NHRA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
- Represent Zahrawi in NHRA and different authorities.
- Negotiate with regulatory authorities for marketing authorization.
- Attend and respond to calls and emails from customers, the Sales team and other support staff.
- Assist the Warehouse Coordinators with relevant documents when requested.
- Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to NHRA importation.
- Keep track of all registration application on Zahrawi’s tracking system.
- Record all active Zahrawi licenses on the Shared folder and ensure they are updated.
- Education: Bachelors Degree in Pharmacy
- Additional details:
- Candidates must be based in Bahrain and should be willing to move to company visa (when applicable)
- Candidates must have a valid Pharmacist license
- Experience: 3 + years of relevant experience in regulatory affairs within Bahrain.
- Job Specific Skills: Excellent Interpersonal Skills & Good English – Good computer skills in Ms. Office (Excel– ERP/Oracle system) - Knowledge about Regulatory Affairs, Product Classification and Importation Regulations as per NHRA