Medical Safety Lead / Sr Medical Safety Lead (CRM)

Novartis Farmacéutica; Barcelona; Híbrido; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company seeks a Medical Safety Lead in Barcelona to ensure safe market introduction of compounds. The role involves monitoring clinical safety, performing medical assessments, and collaborating across departments. Candidates should have a medical degree and experience in drug development.

Formación

• Experience in drug development and patient safety within a pharmaceutical company.
• Knowledge of clinical trial methodology, regulatory standards, and scientific research.

Responsabilidades

• Monitor clinical safety of projects/products, including literature review and case evaluation.
• Prepare safety data for Health Authority reviews.
• Contribute to departmental goals and objectives.

Conocimientos

Clinical Trials

Team Collaboration

Literature Review

Management Skills

Medical Information & Records

Medical Strategy & Compliance

Safety Science

Educación

Medical Degree

PhD

PharmD

Descripción del empleo

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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