Physician / Head of Safety Evaluation & Trial

vor 2 Wochen


Frankfurt am Main, Deutschland Proclinical Vollzeit

**Aufgaben**:

- Fachliche und disziplinarische Führung Ihres Teams von derzeit sechs Mitarbeitenden sowie Übernahme der Planung und Verantwortung des zugewiesenen Budgets.
- Aktive Unterstützung der klinischen Entwicklungsprogramme.
- Gestaltung und konsequente Weiterentwicklung der in Ihrem Arbeitsbereich notwendigen Prozesse.
- Gewährleistung der Anwendungssicherheit von Arzneimitteln durch state of the art" Signalmanagement inkl. Signaldetektion/Signalevaluierung zu vermarkteten und in klinischer Entwicklung befindlichen Produkten.
- Sicherstellung der Qualität der in Ihrem Bereich erstellten regulatorischen Dokumente, z.B. PSURs, EU-Risk Management Pläne, DSURs.
- Ansprechpartner*in für Behördenanfragen und Anfragen von Niederlassungen in Bezug auf die Arzneimittelsicherheit.
- Bewertung der Risiken, die aus Qualitätsmängel resultieren können.
- Beteiligung an der Vor
- und Nachbereitung von Audits und Inspektionen sowie Repräsentation des eigenen Fachbereiches.

**Profil**:

- Erfolgreich abgeschlossenes Studium der Human
- oder Veterinärmedizin (idealerweise mit Promotion).
- Mehrjährige Berufserfahrung in einem forschenden Pharmaunternehmen oder in einer CRO.
- Erfahrung in der Führung und Anleitung eines Teams.
- Idealerweise Erfahrung in der klinischen Entwicklung (bevorzugt einschließlich Einreichungen zur Marktzulassung).
- Fundierte Pharmakovigilanz (PV) Erfahrung und ein starkes Verständnis der PV-Regulierung.
- Kenntnisse im Umgang mit einer Safety-Datenbank (ARISg, Oracle ARGUS.
- Sehr gute Deutsch
- und Englischkenntnisse.
- Hohe selbständige analytische und konzeptionelle Arbeitsweise sowie Freude am Gestalten und Entwickeln von Prozessen.
- Eigenverantwortliche und strukturierte Arbeitsweise mit sehr gutem Zeitmanagement sowie hohes Maß an Zuverlässigkeit.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-MB1

DrugSafety


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