Medical Safety Lead / Sr Medical Safety Lead (CRM)
Job ID REQ-10038099
May 09, 2025
Spain
Summary
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.
About the Role
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
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