08 ago
|
Novartis
|
Barcelona
08 ago
Novartis
Barcelona
Experteer Overview
Todos los posibles candidatos deben leer con atención los siguientes detalles de este trabajo antes de presentar una candidatura.
In this Medical Safety Lead role, you will apply clinical insight and scientific expertise to evaluate safety data and guide critical safety decisions across the product lifecycle. You will work with global cross-functional teams to protect patients and support medicines used for serious diseases. You will drive safety signal evaluation, contribute to regulatory communications, and help shape safety narratives for submissions. This position offers impact at scale within a leading pharmaceutical environment focused on patient safety and innovative pharmacovigilance. You will collaborate with diverse teams to advance safety outcomes and leverage AI-enabled solutions to enhance processes.
Compensaciones / Beneficios
• Monitor safety data from literature, case reports, and signal detection activities
• Advance AI-enabled pharmacovigilance solutions to streamline processes
• Perform medical assessment of adverse event cases and ensure accurate evaluation
• Identify and monitor safety signals using single-case and aggregate data
• Contribute to regulatory responses and healthcare professional safety inquiries
• Assist in preparing core safety documents such as clinical overviews and summary reports
• Provide medical input to aggregate safety reports and regulatory submissions
• Collaborate across global development teams to integrate safety insights
• Guide adverse event coding, causality assessment, and interpretation of clinical safety data
Responsabilidades
• Degree in Pharmacy, Nursing, Pharmacology, Life Sciences, or a medical degree
• Fluency in written and spoken English
• At least 3 years’ experience in drug development within a pharmaceutical company
• Experience in clinical trial methodology, regulatory xqbhyrx requirements, scientific methodology, and statistical principles
• Strong ability to analyze, interpret, and communicate clinical safety data
• Experience in safety and cross-functional issue management
• Proven experience contributing to safety reports and regulatory documentation
• For medical review of individual case safety reports, medical degree is required
Requisitos principales
• flexible and hybrid working options
• minimum 14 weeks paid parental leave
• insurance plans
• retirement plans
• wellbeing resources
• general recognition programs
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