Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Medical Safety Expert (m/f)
Referenz: -en
Beginn: 06/11
Dauer: 7 MM++
Ort: in Lower Saxony
Branche: Herstellung von pharmazeutischen Grundstoffen
Ihre Aufgaben:
- Detection, evaluation and management of safety signals, incl. the initiation of appropriate response and action
- Review of ICSR and regular review of aggregate data
- Review of the worldwide scientific literature for pharmacovigilance related information
- Preparation and distribution of periodic routine reports
- Development of high quality proactive risk management strategies and development of science-based risk/benefit judgments for assigned marketed and investigational compounds
- Review and contribution to safety relevant sections of Investigator's Brochures, protocols, protocol amendments, progress reports, final reports and informed consent forms for all clinical trials
- Assisting in the establishment of local and global procedures related to the general areas of responsibility
Ihre Qualifikation
- Medical degree or degree in life science (e.g. biologist, pharmacologist)
- Sound experience in the pharmaceutical industry and/or equivalent amount of experience in clinical medicine
- Experience in targeted scientific and medical writing
- Experience in literature research and interpretation of clinical data
- Excellent command of the English language
- Experience in using basic office software (preferably Microsoft Office)
Skills:
- Drug Safety
- Medical Affairs