Non Pharma Products Vigilance Specialist

2 settimane fa

Lodi, Italia IBSA Farmaceutici Italia A tempo pieno

La risorsa, inserita all’interno del Dipartimento della Farmacovigilanza della Società e a diretto riporto della Sr Drug Safety Unit Manager, si occuperà del mantenimento di sistema di vigilanza implementato per garantire il monitoraggio del profilo di sicurezza dei prodotti non farma (dispositivi medici, cosmetici e integratori).

In particolare, la risorsa sarà responsabile dello svolgimento delle seguenti attività:

- Garantire la corretta raccolta, valutazione e archiviazione di tutte le segnalazioni ricevute dal post-market e occorse durante la sperimentazione clinica;
- Sottomettere incidenti gravi, eventi indesiderati gravi e/o informazioni di sicurezza valutate come “reportable” occorsi alle Autorità Competenti e/o Enti Certificatori;
- revisionare i contratti di Vigilanza con le parti Terze
- Collaborare nella preparazione dei rapporti annuali di sicurezza (Rapporti sulla sorveglianza post-commercializzazione/ Rapporti periodici di aggiornamento sulla sicurezza) con il supporto di QA e Regolatorio;
- Collaborare nella revisione e aggiornamento delle procedure operative inerenti alle attività di vigilanza;
- Revisionare protocolli clinici e fornire nuovi inputs, dando supporto al team preposto allo sviluppo clinico del prodotto.

**Requisiti**:

- Laurea in discipline scientifiche;
- Esperienza di 1/2 anni nel ruolo o nell’ambito del monitoraggio della sicurezza dei prodotti farmaceutici;
- Conoscenza dell’inglese tecnico di base e della normativa di riferimento;
- Conoscenza di nozioni mediche di carattere generale e di carattere scientifico relative ai prodotti farmacologici.

**Si offre contratto di assunzione a termine per sostituzione maternità.**

**Sede di lavoro**: Lodi (LO)

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