Senior Medical Safety & Clinical Development Lead

F. Hoffmann-La Roche AG; Wien; Hybrid; EUR 39.000 - 47.000; Vollzeit

Zusammenfassung

Roche is seeking a Clinical Development Lead and Medical Safety Physician to oversee the safety lifecycle of Roche-branded products in Austria. You will deliver Medical Risk Assessments and health hazard evaluations, drive regulatory communications, and provide expert medical guidance for postmarket issues.

You will collaborate across R&D, premarket, postmarket quality, and vigilance, acting as the medical authority with strong decision-making and collaborative skills.

Qualifikationen

• Degree in Human Medicine (MD or equivalent) with hands-on clinical experience.
• Medical licence or equivalent registration preferred.
• Experience with applied laboratory medicine and diagnostic methodologies is advantageous.

Aufgaben

• Conduct medical risk analyses (Health Hazard Evaluations, Medical Risk/Safety Assessments, Safety Board meetings).
• Process inquiries from international regulatory authorities on adverse event reporting and recalls.
• Prepare internal and external medical safety evaluations and expert opinions for diagnostics products.
• Plan and run internal trainings to optimize CIR and Medical Safety interfaces.
• Represent Medical Safety in Safety Board processes and inform board decisions.
• Maintain and update SOPs/GSPs and other procedural documents.

Kenntnisse

Medical Education

Clinical Diagnostics

Regulatory Standards

Risk Management

Interpersonal Skills

English Proficiency

Ausbildung

MD or equivalent

Jobbeschreibung

Roche is seeking a Clinical Development Lead and Medical Safety Physician to oversee the safety lifecycle of Roche-branded products in Austria. You will deliver Medical Risk Assessments and health hazard evaluations, drive regulatory communications, and provide expert medical guidance for postmarket issues.

You will collaborate across R&D, premarket, postmarket quality, and vigilance, acting as the medical authority with strong decision-making and collaborative skills.