Pharmacovigilance Manager
Vor 3 Tagen
QA-Support mit Perspektiven in der Pharma Dienstleistung – Baselland
Unser Kunde ist ein etabliertes Beratungs- und Dienstleistungsunternehmen, das nationale und internationale Pharma- und Healthcare-Unternehmen bei der Zulassung und Entwicklung von Arzneimitteln unterstützt. Für zahlreiche Zulassungen agiert die Agentur auch als Zulassungsinhaberin. Ein Team von rund 10 hochqualifizierten Mitarbeitenden sorgt für die Einhaltung höchster Qualitäts- und Sicherheitsstandards der betreuten Arzneimittel.
Zur Verstärkung des Teams suchen wir eine engagierte und erfahrene Fachperson im Teilzeitpensum.
Ihre Aufgaben:
- Sicherheitsmanagement: Verwaltung und Verarbeitung von Meldungen zu unerwünschten Ereignissen gemäß lokalen und internationalen Vorschriften sowie unseren internen SOPs.
- Partnerkoordination: Abgleich von Sicherheitsdaten mit Partnern.
- Signalmanagement: Unterstützung bei Behördenanfragen, Signal-Screening und Meldungsaktivitäten.
- Regelwerk-Pflege: Weiterentwicklung und Pflege lokaler SOPs und Prozesse.
- Verantwortungsfunktion: Übernahme der Rolle der Local Qualified Person for Pharmacovigilance (LQPPV).
- Literaturrecherche: Unterstützung und Durchführung lokaler wissenschaftlicher Literaturrecherchen.
Ihr Profil:
- Hochschulabschluss in einem Life-Science-Fach (z. B. Medizin, Pharmazie, Biowissenschaften oder Krankenpflege).
- Mindestens 2 Jahre Berufserfahrung in der Pharmakovigilanz.
- Fundierte Kenntnisse der schweizerischen Vorschriften zur Pharmakovigilanz sowie der internationalen Standards (ICH-GCP, EU-GVP).
- Sicherer Umgang mit Microsoft Office.
- Sprachkompetenzen: Fließend in Deutsch und Englisch (Business Level); Französisch und/oder Italienisch sind ein Plus.
Sie sind aufgeschlossen, selbständig und gewissenhaft. Sie sind eine service-orientierte Person mit klarer schriftlicher und mündlicher Kommunikation.
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