Beschreibung
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
Drug Safety Officer (m/f)
Referenz: -en
Beginn: asap
Dauer: 3 MM++
Ort: in Hesse
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Direct report to the Director of corporate drug safety medical evaluations plasma proteins. Activities may involve:
- Independent medical evaluation of safety information reported by suspected adverse drug reactions, adverse events, pharmaceutical technical complaints.
- This includes contact to all sorts of reporters of safety information, including physicians, pharmacists, consumer, health authorities
- Performing signal detection according to the clinets Standards
- Timely reporting to health authorities according to the standards
- Processing safety information within the pharmacovigilance database (VigilanceOne)
- Writing aggregate safety documents like PSUR, Risk Management Plans, Annual Safety Reports
- Representation of CDS within clinical teams in investigational products, preparing safety parts in Investigator brochure, Investigational Medicinal Products Dossier etc.
- home office based is an option
Ihre Qualifikation
- Education:
- Academic Health Professional -preferrably physician- with experience in Drug Safety, preferably plasma proteins. Further Experience:
- Writing, at least contributing to PSUR, Risk Management Plans;
- Pharmacovigilance in Clinical Trials (investigator brochure, IMPD, risk/benefit assessments)
- Knowlegde in international pharmacovigilance regulations, in particular Vol 9a.
- Experience in databases
- Knowledge in MS Office
- Fluent English, understand German
Skills:
- Drug Safety