Product Safety Associate

vor 2 Wochen

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Jobbeschreibung

Wir suchen einen erfahrenen Product Safety Associate, der sich in unserem Team für Global Case Management einbringen möchte.

Hauptraum

Als Product Safety Associate sind Sie für die Sicherstellung der Compliance bei der Prozessierung von Nebenwirkungsmeldungen verantwortlich. Sie werden die eingehenden Berichte zu Nebenwirkungsmeldungen aus dem Spontanmeldewesen oder aus klinischen Studien erfassen, kodieren medizinische Fachbegriffe nach MedDRA in der elektronischen Datenbank und überwachen den gesamten Ablauf der Fallbearbeitung durch unseren Dienstleister.

Verantwortlichkeiten
  • Erfassen von Nebenwirkungsmeldungen und deren Kodierung nach MedDRA
  • Überwachung des gesamten Ablaufs der Fallbearbeitung
  • Anzeigen von Nebenwirkungsmeldungen an die zuständigen Behörden
  • Koordination und Erstellung von Queries zum Einholen von Zusatzinformationen
  • Durchführung und Dokumentation der Rekonzilierung erhaltener und ausgetauschter Nebenwirkungsmeldungen
  • Erstellung und Pflege pharmakovigilanzrelevanter Standardarbeitsanweisungen
  • Vorbereitung, Teilnahme und Nachbereitung von Behördeninspektionen und internen Audits
Qualifikationen
  • Abgeschlossene Ausbildung als Medizinische/r Dokumentar/in oder eine vergleichbare pharmazeutische bzw. medizinische Ausbildung
  • Mehrjährige Berufserfahrung im Bereich Arzneimittelsicherheit / Drug Safety
  • Erfahrung in der Konfiguration und Validierung von Sicherheitsdatenbanken und im Vendor Management
  • Fundierte Kenntnisse in der medizinischen Terminologie mit Erfahrungen in der Kodierung nach MedDRA
  • Sichere Deutsch- und gute Englischkenntnisse in Wort und Schrift
  • Idealerwiese Erfahrungen im Umgang mit einer elektronischen Sicherheitsdatenbank
  • Sehr gute Selbstorganisation, Zuverlässigkeit und eine sorgfältige Arbeitsweise
Benefits
  • Individuelle Karriereentwicklung in einem sinnstiftenden Beruf
  • Hybrides Arbeitsmodell, das eine ausgewogene Work-Life-Balance ermöglicht
  • Attraktiver Standort mit guter Verkehrsanbindung
  • Internationales Familienunternehmen mit flachen Hierarchien und einer offenen, wertschätzenden Unternehmenskultur
  • Attraktive Vergütung mit umfangreichen Sozialleistungen

Wir freuen uns darauf, Sie als Teil unserer internationalen und motivierten Merz Therapeutics Familie begrüßen zu können.

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