Pharmacovigilance Manager

وصف الوظيفة

مطلوب Pharmacovigilance Manager. من المتطلبات: Very good command of English, written and spoken.. للتقديم يرجى إرسال السيرة الذاتية إلى البريد الإلكتروني المذكور.

المهام والمسؤوليات

• Manage and oversee the company’s Pharmacovigilance activities and ensure compliance with applicable local and international regulations.
• Establish, maintain, and continuously improve the company’s Pharmacovigilance system and procedures.
• Ensure the timely collection, assessment, documentation, and reporting of adverse drug reactions (ADRs) and safety information.
• Review and follow up on Individual Case Safety Reports (ICSRs), including serious and non-serious cases.
• Ensure timely submission of safety reports and regulatory notifications to the relevant health authorities.
• Monitor and evaluate the benefit-risk profile and safety information of the company’s products.
• Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) and other pharmacovigilance-related documents.
• Maintain Pharmacovigilance records, databases, and documentation in accordance with applicable requirements.
• Monitor regulatory and safety updates and ensure implementation of relevant requirements.
• Conduct and coordinate Pharmacovigilance training for employees and relevant stakeholders.
• Collaborate with Regulatory Affairs, Medical Affairs, Quality Assurance, and other departments on safety-related matters.
• Support Pharmacovigilance inspections and audits and ensure timely implementation of corrective and preventive actions (CAPA).

المتطلبات

• Very good command of English, written and spoken.

تعليمات التقديم

التعليقات

لا توجد تعليقات منشورة حتى الآن.