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Medical Safety Lead / Sr Medical Safety Lead (CRM)
Job ID REQ-10038099
May 09, 2025
Spain
Location: Barcelona, Spain
Working model: Hybrid (12 days/month in-office)
Note: No relocation support provided. Only apply if accessible to this location.
About this role:
As a Medical Safety Lead in the Cardio Renal Metabolic (CRM) area, you'll be part of a team that ensures the safe market introduction of important compounds, aiding millions with serious diseases.
Reporting to the Head of Patient Safety CRM.
Major accountabilities:
- Monitor clinical safety of projects/products, including literature review, case evaluation, and safety question responses.
- Perform medical assessments for cases, including follow-up, evaluation of adverse events, review of case listings, and preparing notifications and assessments for ethics committees.
- Identify safety signals from case reviews.
- Conduct signal detection, monitoring, and evaluation.
- Contribute to responses to regulatory authority or healthcare professional inquiries.
- Prepare safety data for Health Authority reviews.
- Assist with legal and country-specific safety queries.
- Provide expert medical evaluation of adverse event reports and their implications.
- Collaborate with clinical safety teams across departments.
- Contribute to departmental goals and objectives.
Role Requirements:
Education & Experience:
- Medical Degree preferred; PhD or PharmD considered.
- Experience in drug development and patient safety within a pharmaceutical company.
- Knowledge of clinical trial methodology, regulatory standards, and scientific research.
- Ability to analyze and communicate safety information effectively.
- Experience in safety assessments and regulatory submissions.
- Experience in issue management.
Languages:
- Fluent in English (spoken and written); additional EU languages advantageous.
Skills:
- Clinical Trials
- Team Collaboration
- Literature Review
- Management Skills
- Medical Information & Records
- Medical Strategy & Compliance
- Safety Science
Why Novartis: Join us in transforming patient lives through innovation and collaboration. Discover more: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right role? Sign up to stay connected: https://talentnetwork.novartis.com/network
We are committed to diversity and inclusion, reflecting the communities we serve.
* El índice de referencia salarialse calcula en base a los salarios que ofrecen los líderes de mercado en los correspondientes sectores. Su función es guiar a los miembros Prémium a la hora de evaluar las distintas ofertas disponibles y de negociar el sueldo. El índice de referencia no es el salario indicado directamente por la empresa en particular, que podría ser muy superior o inferior.
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