Drug Safety Physician

Vor 6 Tagen


Munich, Bayern, Deutschland 9ff93bfa-fe15-479a-a153-2c02173c0d0c Vollzeit 90.000 € - 120.000 € pro Jahr

Drug Safety Physician (Freelance)

Ort:
Remote / München

Start:
ASAP

Dauer:
6-12 Monate

Umfang:
30-40 Std./Woche

Ihre Aufgaben

  • Aggregate Reports (PSUR/DSUR):
    Leitung des Projektmanagements für die Erstellung von PSUR/DSUR für mehrere vermarktete Produkte in Europa inkl. Vendor-Steuerung, Planung, Prozessüberwachung und Dokumentenmanagement.
  • Risk Management:
    Beratung bei der Aktualisierung von EU-RMPs, Signal Detection/Assessment Reports und Bewertung neuer Signale.
  • Safety Communication:
    Entwicklung von Strategien zur internen und externen Kommunikation sicherheitsrelevanter Informationen inkl. EU-Risk-Minimisation-Aktivitäten.
  • Dokumentation & Tracking:
    Selbstständige Protokollierung von Meetings, Entscheidungen und Maßnahmen sowie Pflege des Signal-Trackings.
  • Projektmanagement:
    Sicherstellung der Einhaltung von Projektzeitplänen für sicherheitsrelevante Themen.

Must Haves:

  • Mindestens
    8 Jahre Erfahrung in Drug Safety
  • Erfahrung in
    klinischen Studien
  • Expertise in
    Onkologie
    und
    Biologics
  • Medical Doctor


Haben Sie Interesse?
Bewerben Sie sich jetzt

Herzliche Grüße aus München,

Stefan Blöchl


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