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Drug Safety Specialist (50%) (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Marketing

Projektbeschreibung

REFERENZNUMMER:

331279/11

IHRE AUFGABEN:

-Set up and maintain safety process for assigned clinical studies (e.g. safety management plan, reconciliation)
-Case processing activities from clinical studies and post-marketing experience
-Manage updates and revisions of safety data exchange agreements (SDEA) and be involved in the preparation of new SDEAs
-Preparation of aggregate safety reports (DSUR, PSUR)
-Be involved in updates of PV SOPs and of processes at safety CRO
-Maintenance of the pharmacovigilance system master file (PSMF)
-Ensure that all adverse event reports are processed according to SOPs
-Filing and archiving of relevant safety information as required

IHRE QUALIFIKATIONEN:

-Advanced degree in Life Sciences (Minimum Bachelor)
-Solid experience in pharmacovigilance/drug safety, ideally at headquarters level
-Used to interact with other departments (e.g. Clinical Development, Regulatory Affairs)
-Fluent in English (verbal and written), other languages are of advantage (e.g. French, German, Italian)
-Working knowledge of EU pharmacovigilance requirements for investigational and marketed compounds
-MS Word, Excel, PowerPoint skills
-Good written and verbal communication skills

WEITERE QUALIFIKATIONEN:

Drug safety assistant

Projektdetails

  • Einsatzort:

    Basel-City, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12 MM++

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Marketing/Vertrieb

  • Skills:

    marketing

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland

  • Projekte:

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