Job Description
Job DescriptionRegulatory Affairs & PV Team Leader (KSA) - (457)About Zahrawi GroupZahrawi 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 accountable in management of products safety procedures, in accordance to the SFDA Pharmacovigilance requirements and to act as Pharmacovigilance Officer ensuring accurate and prompt reporting of adverse event reported to DAZM. They are also responsible for making sure that all our products are classified and registered as per SFDA guidelines. *ACCOUNTABILITIESPolicies & Procedures: Adhere to all Zahrawi Policies & Procedures as applicable. Team Management: Ensure that team members meet the performance goals assigned to them. Collect periodic reports from team. Delegate short-term targets for the team members. Establish regulatory priorities and allocate resources and workloads. Train team members on regulatory policies or procedures. Help the team members solve task related problems. Motivate the team members and making sure that they are following the policies and procedures. Pharmacovigilance: Follow the Pharmacovigilance guidelines of SFDA 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 communicate the same to the Suppliers and stakeholders as per SFDA guidelines. Recall and Field Action Reports: Report any spontaneous Individual Adverse Event to the Supplier and the Health Authority. Maintain a soft and hard copy of all Adverse Event for the future. Track and follow up with all active Recall, Field Action and Adverse Event reconciliation with the respective Division Managers and Suppliers and maintain a record. Report all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities. Regulatory Affairs: Ensure that Zahrawi’s products comply with the regulations of the SFDA. 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. 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 Registration under SFDA. Prepare all required documents to be submitted for Manufacturing Site registration under SFDA. Prepare all the Dossiers to be submitted to SFDA for medical and IVD products. Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System. Importation Permits: Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required. Prepare and submit the required documents to obtain the import permits for restricted elements from SFDA & MOI. Apply and submit the permits through Ghad system. 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 weekly / monthly report regarding the rejections/ delays for SFDA importation permits and reasons related to that. Exportation Permits: Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA. Note: Zahrawi employees must step into other work assigned to them as business needs arise and are not limited to the above. *REQUIREMENTS Education: Bachelor’s degree Experience: 5+ years of relevant experience in regulatory affairs (for medical devices in KSA) Job Specific Skills: Effective Communication skills & Good English - Time management skills - Problem Solving Skills - Good computer skills in Ms. Office (Excel– ERP/Oracle system) – Process Management skills – Detail Oriented - Ability to work under pressure – Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations - Leadership skills. Additional Details: Candidate should be Saudi National and based in Riyadh, KSA. Location:KSA - Riyadh Job Type:FULLTIME Job Posting Date:27-10-2024 Division/Department:Regulatory Affairs and Pharmacovigilance
