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Job Vacancy: Pharmacovigilance Manager Ram Pharmaceuticals Ind. Co. is seeking to recruit a qualified and expe

🕒 قبل 14 يوماً · المصدر: تيليجرام

Job Vacancy: Pharmacovigilance Manager Ram Pharmaceuticals Ind. Co. is seeking to recruit a qualified and experienced Pharmacovigilance Manager to join our team. Key Responsibilities · 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). Qualifications & Requirements · Bachelor’s degree in Pharmacy. · Relevant 7 years of experience in Pharmacovigilance within the pharmaceutical industry, 3 years as preferably in a managerial level. · Strong knowledge of Pharmacovigilance principles, regulations, and safety reporting requirements. · Familiarity with ICSRs, PSURs/PBRERs, signal detection, and benefit-risk assessment. · Excellent analytical, organizational, communication, and problem-solving skills. · Strong attention to detail and ability to manage multiple priorities and deadlines. · Very good command of English, written and spoken. · Strong leadership and interpersonal skills. 📩 How to Apply Interested candidates are invited to send their updated CV to: [email protected] mentioning “Pharmacovigilance Manager” in the subject line.
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