P2603 - Associate Safety Physician — Debiopharm
Role overview
At Debiopharm, every step we take is guided by one purpose: Improving the lives of people affected by cancer and infectious diseases.
As a privately-owned Swiss biopharmaceutical company, we're driven by science, but above all, by the people behind every treatment - the patients and their families.
Through our unique "development only" model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster.
Key requirements
- Medical Safety Oversight: Manage project safety profiles and conduct individual/aggregate medical reviews within the safety database.
- Clinical Support: Provide expert medical input for study protocols, Investigator Brochures (IBs), and Development Safety Update Reports (DSURs).
- Signal Detection & Surveillance: Lead ongoing safety monitoring and signal detection, particularly during early-phase clinical trials.
- Cross-Functional Collaboration: Partner with Clinical, Regulatory, and Biostatistics teams to ensure clinical programs support robust safety assessments.
- Stakeholder Representation: Represent Safety in study teams, internal task forces, and external meetings like IDMCs.
- Regulatory & Compliance: Contribute to safety sections of IND/NDA submissions and maintain inspection readiness for audits/inspections.
- Medical Credentials: Medical Doctor (MD) with 2/3years of clinical/pharma experience or a Physician with research fellowship experience.
- Technical Expertise: Proven ability in medical review, data analysis, and safety surveillance within clinical studies.