Medical Safety Expert
2 days ago
**Summary**:
È responsabile dei programmi di monitoraggio dei farmaci, compresa la necessità di monitorare le segnalazioni di eventi avversi, di valutare il rischio e la pertinenza dei prodotti, di monitorare la sicurezza delle sperimentazioni cliniche e di monitorare i programmi post-marketing. Partecipare nel rispetto di tutti gli obblighi e regolamenti legali. Garantisce e contribuisce all'identificazione delle tendenze e delle indicazioni di sicurezza e alla valutazione della gestione del rischio per il ciclo di vita del prodotto. Fornisce un supporto sicuro ai team di sviluppo clinico.
**About the Role**:
Major Accountabilities
~ L'aiuto è concesso in base alle esigenze delle attività di approvvigionamento, vale a dire
~ Monitorare la sicurezza del prodotto, incluso il monitoraggio della documentazione, le valutazioni mediche individuali/casi o il rilevamento del segnale.
~ Revisione della letteratura esecutiva
~ Assistenza nella preparazione di indagini individuali presso il Ministero della Salute, in particolare per quanto riguarda le richieste di notifiche a breve termine.
~ seguito della relazione di valutazione delle autorità sanitarie.
~ Aiuta a implementare in modo sicuro i problemi normativi e i documenti clinici. Sostegno alla manutenzione e alla gestione delle anomalie locali
~ Assistenza nella valutazione e preparazione di altre
~ Supporto per le nuove linee guida per la presentazione (accesso legale alla sicurezza dei documenti) se necessario.
~ Siate pronti a rispondere a una richiesta di sicurezza nazionale e gestire una richiesta di sicurezza esterna.
~ Esperto in procedure mediche/interventi medici (PMI)
~ Gestione della formazione e dell'orientamento dei giovani/colleghi
~ Distribuzione di campioni di marketing (se del caso)
Key Performance Indicators
Velocità e qualità dellanalisi, interpretazione e presentazione della sicurezza
Conformità alle normative e alle procedure interne ed esterne
Mantenere sicurezza, coerenza e qualità
Work Experience
~Operations management and execution
~Project Management
~Collaborazione intraziendale
~Estensione funzionale
~Criticità relative alla gestione di persone
~Gestione di crisi
**Skills**:
~Ricerca Clinica
~Sicurezza di processo
~Conformità normativa
~Team funzionali
~Scienza della sicurezza
~Revisione della letteratura
~Cartelle cliniche
~Clinici
Language
Inglese
Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regolare
Shift Work
No
**Accessibility and accommodation**:
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