Experienced Drug Safety Scientist
We are looking for an experienced drug safety scientist with expertise in Rheumatoid arthritis (or immunology or infectious disease), for one of our clients based in Gent.
Option to be 3 days based at the client site and 2 days off-site (homebased or at Keyrus offices).
- Oversight of safety activities outsourced;
- Review (quality control) of safety narratives (written by suppliers);
- Clinical assessment, monitoring and evaluation of the risks associated with the use of a drug in pre- and post-marketing phases;
- Review of Safety reports (DSURs,....);
- Definition/review of queries;
- Quality check and production of line listings in order to conduct the reconciliation between the clinical and safety databases.
- Physician or experienced PV scientist;
- 3 to 5 years of expertise in Rheumatoid Arthirtis (or infectious desease or immunology);
- Knowledge of GCP and ICH Guidelines;
- Good knowledge of the new EU PV regulation (GVP);
- Good knowledge of the coding dictionaries (MedDRA and WHO-DD);
- Fluent in oral and written English;
- Good command of Microsoft Office tools (Excel, Word, PowerPoint);
- Excellent scientific/clinical and analytical knowledge, with ability to evaluate data and to understand the safety/medical implications;
- Good understanding of the significance of clinical, epidemiological or more generally scientific data;
- Organisation skills, proactivity and autonomy;
- Meticulousness, eye for detail and good interpersonal skills;
- Entrepreneurship and responsibility.