Pharmacovigilance and logistics safety associate

Pharmacovigilance and logistics safety is the point of convergence between medical research, regulatory affairs, supply chain, and marketing. Its role is increasingly important in today’s regulated environment, ever more sensitive to the risk prevention/management and transparency of communications. The incoming associate will have assisted oversight over the company’s pharmacovigilance system in a manner that ensures that information on all suspected adverse reactions and concerns is reported internally, to medical representatives, and to the SFDA in an accurate and timely manner. The opportunity is best suited for Riyadh based young Saudi males or females who are eager to develop operational, regulatory, and leadership skills.
المهارات
Key Responsibilities:
• 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
• Saudi national
• Ability to keep meticulous records and attention to details
• Ability to interact and communicate effectively with a wide range of people
• A systematic approach to tasks• Good interpretative and teamwork skills
Package: SAR 12,000 take-home pay, including benefits (revised annually depending on performance).
: مصادر خارجيه
: 5500
: طب وصيدلة وعلوم
: الرياض , السعودية
: دوام كامل
: 8 ساعات
: 2018-02-24
: 2018-03-24
: الكل
: لا يشترط
: لا يشترط
: 427

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