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الوصف الوظيفي المهارات • Work with the head of operations and the operations team to continuously improve and maintain the pharmacovigilance system in all its relevant aspects (i.e., quality control and assurance procedures, standard operating procedures, database, contractual arrangements, compliance, etc.) • Timely and accurate submission of reports to the SFDA (i.e., ADR, PSURs, ICRs) • Stay informed on the safety profiles and any emerging safety concerns of the company’s registered medicinal products and continuous pharmacovigilance evaluation pre and post medicinal product registration with the SFDA • Ensure full compliance with handling and shipping requirements/regulations for incoming and outgoing shipments and inform staff and management of any regulatory developments • Good understanding of published SFDA pharmacovigilance and warehouse regulations, guidelines, and literature • Liaise with the SFDA on drug and medical devices registration, import license approval, or customs clearance. • Ensure audit and pharmacovigilance inspection preparedness and act as the SFDA’s contact point for inspections and audits • Act as the single emergency point of contact with the SFDA (on a 24-hour basis) Qualifications and requirements: • Bachelor of Pharmacy (or equivalent) degree Package: SAR 12,000 take-home pay, including benefits (revised annually depending on performance). الخلفية التعليمية تفاصيل الوظيفة https://www.bayt.com/ar/saudi-arabia/jobs/pharmacovigilance-and-logistics-safety-associate-3775144/ |
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