Job Description
Your challenge :
1. Medical Monitoring of Clinical trialsMedical review of clinical trial protocols and inputPreparation of medical monitoring planMedical input to internal parties (Feasibility, Data management, Statistics, Medical writing)Answering trial/protocol related questions from investigators, including inclusion/exclusion criteria, use of concomitant and prohibited medications, subject’s disease states or pre-existing conditions, adverse events, potential protocol violations/deviations, laboratory and ECG results/alerts, other trial specific investigationsAct as 24/7 available medical contact personMedical Review of eCRF (medical consistency of clinical and safety data, identification of any medical issue, medical review of coding)Medical review of clinical study report (CSR)Open and regular communication with sponsors
2. Medical Review of clinical and post marketing safety dataMedical review of individual case safety report (ICSR): adverse events (AEs), Serious adverse events (SAEs), adverse drug reactions (ADR)Medical review of listings of safety dataMedical input and review of PSUR, DSUR, other benefit risk assessment reports
3. Scientific and medical literature search and medical review of literature results in view of benefit/risk reports
4. Able to summarize medical/scientific reports for inclusion in benefit/risk reports
Qualifications
5. Medical Doctor (MD)
6. At least 1-year clinical experience as a medical doctor or in a medical position in pharmaceutical industry or in a CRO
7. Quality minded; eye for detail and being able to make distinction between main and side issues
8. Respecting budgets and timelines
9. Being able to prioritize issues according to importance
10. Languages: fluent English, both written and spoken
Please not we cannot support a work permit procedure.