Global Safety Manager
Negotiable
Preclinical
Baden-Württemberg
Permanent
Hybrid

Global Safety Expert (m/w/d) | Pharma | BaWü

Für die Unterstützung des Teams sucht der exklusive Kunde einen engagierten Pharmakovigilanz-Experten (m/w/d). In dieser Rolle übernehmen Sie die globale Pharmakovigilanz-Produktverantwortung für die zugewiesenen Arzneimittel.

Ihre Aufgaben:

  • Überwachung des Nutzen-Risiko-Profils und Signal Management
  • Durchführung von Risikomanagement-Aktivitäten, einschließlich der Erstellung von Risk Management Plänen sowie der Betreuung von Risikominimierungsmaßnahmen
  • Erstellung periodischer Sicherheitsberichte
  • Betreuung von interventionellen und nicht-interventionellen Studien sowie weiterer Datenerhebungsaktivitäten, einschließlich der Erstellung und Überprüfung studienspezifischer Dokumente
  • Unterstützung bei der Erfüllung der Pharmakovigilanz-Verpflichtungen, insbesondere:
    • Sammlung, Dokumentation und Bewertung von Arzneimittelrisiken, wie unerwünschte Arzneimittelwirkungen, Wechselwirkungen und Gegenanzeigen
    • Medizinische und wissenschaftliche Bewertung von Risiken und deren Dokumentation unter Berücksichtigung gesetzlicher Meldepflichten
    • Weitergabe relevanter Informationen an Pharmakovigilanz-Abteilungen bei Dienstleistern, Lizenznehmern, Vertriebspartnern und Tochtergesellschaften
    • Unterstützung bei der Erstellung von Pharmakovigilanzverträgen sowie bei GVP-Inspektionen und Audits
    • Erstellung und Pflege der Pharmakovigilanz-Stammdokumentation (PSMF) sowie von Standard-Arbeitsanweisungen (SOPs)
    • Schulung von Mitarbeitenden und Partnern im Bereich Pharmakovigilanz
    • Management der Fallbearbeitung und Literatursuche sowie Pflege der Pharmakovigilanz-Datenbank

Ihr Profil:

  • Erfolgreich abgeschlossenes Studium der Humanmedizin
  • Fundierte Berufserfahrung im Bereich Pharmakovigilanz
  • Ausgeprägte Teamfähigkeit und Kommunikationsstärke
  • Sehr sorgfältige und genaue Arbeitsweise sowie hohe Zuverlässigkeit
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

Das bietet der Kunde:

  • Eine spannende und verantwortungsvolle Tätigkeit in einem dynamischen Umfeld
  • Ein motiviertes und kollegiales Team
  • Möglichkeit zur fachlichen und persönlichen Weiterentwicklung

Weitere Vorgehensweise:

Sie interessieren sich für diese Position? Dann schicken Sie mir gerne Ihren aktuellen Lebenslauf zu und ich vereinbaren ein erstes Gespräch mit Ihnen.

E-Mail: M.Inderhees@sciproglobal.de

Tel: 08926200925

Ich freue mich auf Ihre Bewerbung!

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We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.