The 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.

They are also responsible for the preparation of the pre- and final permits for the imported items as per the MOH guidelines.

ACCOUNTABILITIES

Policies & Procedures:

  • Adhere to all Zahrawi Policies & Procedures as applicable.

Regulatory Affairs:

  • 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.
  • Provide advice about regulations to customers/suppliers.
  • Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

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 all the Dossiers to be submitted to MOH for product registration.
  • Collect all necessary documents from Supplier to submit for Ministry of Environment.

Importation Permits:

  • Prepare and apply for the pre-permit document as per the MOH guidelines and verify the items being imported and the documents required.
  • Apply for the MOH regulated products permits on the MOH website as per the specified guidelines.
  • Register and submit the permits for Ministry of Environment.
  • Apply for the final approval of the items being shipped through the MOH, once shipments received to the port and coordinate with logistic team for the same.
  • 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 MOH importation permits and reasons related to that. 

Importation Rules & Regulations:

  • 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.
  • 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 MOH guidelines of imported shipments and take the corrective and preventive action accordingly.
  • Review on a regular basis the MOH importation process of distribution agreements.
  • Ensure that the MOH 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 MOH regulated or not.
  •  Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

Pharmacovigilance:

  •  Responsible for all Pharmacovigilance related work and assigned as the LRPPV (Local Responsible Person for Pharmacovigilance)
  • Perform regulatory intelligence by screening the MOH 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.
  • 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.

Quality Assurance:

  • 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 MOH 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 MOH 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.

Audit:

  • 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.

Admin:

  • Develop a professional relationship with the MOH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
  • Represent Zahrawi in the MOH 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 MOH 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.

REQUIREMENTS

  • Education: Bachelors Degree in Pharmacy
  • Additional details:
    • Candidates must be based in Oman (Omani national)
    • Candidates must have a valid MOH Pharmacist license.
  • Experience: 2+years of experience as applicable - Regulatory Affairs experience in Medical Devices/Pharmaceutical field. Warehouse Pharmacist experience preferred.
  • Job Specific Skills: Require a good knowledge in Importation experience through MOH, Environment Portals, HS Codes/ Customs Portal.

Salary

0 - 0 AED

Monthly based

Location

Muscat , Oman

Job Benefits
Distribution team
Job Overview
Job Posted:
3 months ago
Job Type
Full Time
Job Role
Pharmacist
Education
Bachelor Degree
Experience
2 Years
Total Vacancies
1

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Location

Muscat , Oman