Medical Safety Expert

2 days ago


Hyderabad Telangana, India Novartis Full time

**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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