Overview
In this Basel-based contract role, you will lead safety oversight for early-phase trials in immunology and inflammation, ensuring high-quality pharmacovigilance and data review. You will work closely with cross-functional teams to shape safety strategy and medical reviews. The position supports a fast-moving biotech aiming to bring transformative therapies to patients. This opportunity offers meaningful impact within a collaborative, international environment in Basel.
Verantwortungsbereiche
- Medical monitoring and pharmacovigilance activities including study oversight and safety data review
- Perform causality assessments for suspected adverse events
- Review coding activities (MedDRA) and safety data processing
- Conduct safety reviews of clinical and diagnostic data and contribute to case processing and aggregate reporting
- Provide medical review of aggregate reports (DSUR) and support development of medical review procedures
- Contribute to design, execution, and reporting of Ph1/2 trials in I&I space
- Contribute to medical development strategy and safety/efficacy data analysis
- Prepare clinical documents (protocols, amendments) and review related safety plans and monitoring plans
- Collaborate with Clinical Operations and Clinical Biomarker teams to meet program milestones
- Support development of statistical analysis plans and interpretation of trial data
- Ensure safety data handling aligns with GCP/SOPs and corporate strategy
Zentrale Anforderungen
- MD degree
- Several years of clinical research or development experience in pharma/biotech, preferably in early trials
- Strong knowledge of clinical trial methodology and regulatory/compliance requirements
- Knowledge of GCP/GLP and trial design
- Ability to work in multi-centre CRO/CDO environments and cross-functional settings
- Experience in autoimmune disease and/or IBD (I&I) space preferred
- Permits or Swiss/EU citizenship/ residency as required
- Pro-active and passionate medical professional
- Team player with ability to lead or contribute in diverse teams
- Strong communication and collaboration across functions
- Pharmacovigilance and medical monitoring
- Causality assessment
- MedDRA coding
Safety Physician in Basel Arbeitgeber: CTC Resourcing Solutions
CTC Resourcing Solutions bietet eine herausragende Arbeitsumgebung für Fachkräfte im Bereich Biotechnologie und Pharma. Mit einem starken Fokus auf Teamarbeit und interdisziplinäre Zusammenarbeit in Visp, Schweiz, fördern wir eine Kultur der kontinuierlichen Verbesserung und beruflichen Weiterentwicklung. Unsere Mitarbeiter profitieren von flexiblen Arbeitszeiten, umfassenden Schulungsprogrammen und der Möglichkeit, an innovativen Projekten in einer dynamischen Branche teilzunehmen.
