Drug Safety Physician
Vor 6 Tagen
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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