Medical Safety Lead – CRM
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: Barcelona • Spain
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Job Level
About the role
- Monitor clinical safety data, literature, and case reports to identify potential safety signals
- Conduct medical assessments for individual cases, including follow-ups and quality defect evaluations
- Perform signal detection and evaluation using aggregate and single-case data
- Contribute to regulatory responses and prepare safety data for health authority reviews
- Support safety input for core data sheets and related regulatory documentation
- Provide medical input for aggregate safety reports and risk management plans
- Collaborate with cross-functional teams on clinical safety deliverables and study documentation
- Offer expert evaluation on adverse event reports and guide pharmacovigilance operations
Requirements
- Master of Science / PharmD / PhD in a relevant field
- Fluent in spoken and written English; additional language skills are a plus
- Minimum 4 years of experience in drug development, including 2 years in patient safety
- Strong knowledge of clinical trial methodology, regulatory requirements, and scientific analysis
- Proven ability to interpret and present safety data clearly and effectively
- Experience contributing to clinical safety assessments and regulatory safety reports
Benefits
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
signal detectionmedical assessmentsquality defect evaluationsregulatory responsessafety data preparationaggregate safety reportsrisk management planspharmacovigilance operationsscientific analysisclinical trial methodology
Soft Skills
communicationcollaborationevaluationinterpretationpresentation
Certifications
Master of SciencePharmDPhD