Pharmacovigilance Expert with Global Reach
hace 6 días
Are you interested in a challenging role that involves helping to detect, prevent problems, and evaluate adverse drug reactions? We are seeking an experienced Pharmacovigilance Expert to join our team at Empresa Reconocida.
Main Responsibilities:
• Conduct weekly global or local literature reviews to stay up-to-date on the latest developments in pharmacovigilance.
• Handle and follow-up on Individual Case Safety Reports (ICSRs) in accordance with regulatory requirements.
• Translate information into English for international submissions.
• Collaborate with Spanish Regulatory Authorities on pharmacovigilance matters.
• Serve as a qualified local contact in Spain for pharmacovigilance-related queries and provide support to clients on local legislation.
• Maintain accurate records of pharmacovigilance activities, including PSMF and Asphalion Pharmacovigilance System (SOPs).
• Prepare and submit XEVMPD applications to the European Medicines Agency (EMA) and develop PSURs, RMP, PSMF, and CCSI documents.
• Provide medical advisory services and prepare draft pharmacovigilance contracts.
• Report cases to European authorities through EudraVigilance and process non-serious cases through our database.
Requirements:
• A minimum of 3 years of experience working in pharmacovigilance departments.
• Proficiency in both English and Spanish languages.
• Proven track record of working in an international environment.
• Academic degree in Life Science and Pharmacovigilance.
• Advanced IT skills, particularly in Microsoft Office.
• Strong communication, organizational, and analytical skills.
We offer a competitive salary of approximately €60,000 per year, depending on experience, and a comprehensive benefits package, including flexible work arrangements, social benefits, and opportunities for professional growth and development.
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