Hays

Projektmanager Drug Safey (m/f/d)

Darmstadt | Freelance/Contracting project
Reference number
488861/1
Start date
asap
Project duration
12 MM++
My duties
  • DSUR, PBRER and pSUSAR preparation/project management/ writing up
  • Literature review processes; be able to understand the publications and highlight potential signals or important efficacy information
  • Safety data review using spotfire or other visualization tool at clinical level and for integrated data
  • Use ArisG or other safety databases to generate CIOMS and/or review
  • Surveillance related project management activities (slide preparation for safety committees and boards, meeting minutes., etc)
  • Safety evaluation report writing by applying principles such as Bradford Hill criteria, CTCAE etc.,
  • Project management activities.
  • Other (such as submissions support, launch activities etc.,)
My qualifications
  • Experience with Drug Safety
  • Experience with PSUR, DSUR
  • Knowledge of general case processing and expedited reporting activities
  • Knowledge and experience of CIOMS, GVP, FDA and ICH guidelines
  • Understanding of AESI, CMEs , DMEs and activities surrounding these topics
  • English
My benefits
  • Varied tasks in a renowned company
  • About Hays
    With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
    My contact at Hays

    My contact person
    Julia Brom-Göbel

    Reference number
    488861/1

    Contact
    E-Mail: julia.brom-goebel@hays.de