P2603 - Medico di Sicurezza Associato — Debiopharm
Debiopharm · Lausanne (VD)
Panoramica
In Debiopharm, ogni passo che facciamo è guidato da un unico scopo: migliorare la vita delle persone colpite da cancro e malattie infettive.
In quanto azienda biofarmaceutica svizzera di proprietà privata, siamo guidati dalla scienza, ma soprattutto dalle persone dietro ogni trattamento: i pazienti e le loro famiglie.
Attraverso il nostro esclusivo modello di “solo sviluppo”, portiamo avanti terapie promettenti e le trasformiamo in trattamenti che possono raggiungere coloro che ne hanno più bisogno, più velocemente.
Requisiti principali
- 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.
