Medical Safety Expert

2 days ago


Hyderabad Telangana, India Novartis Full time

**Summary**:
Responsable des programmes de surveillance des médicaments, y compris le suivi nécessaire des rapports sur les réactions indésirables, l’évaluation et la pertinence des risques des produits, la surveillance de l’innocuité des essais cliniques et des programmes post-commercialisation. Participer au respect de toutes les obligations légales et au respect des règlements gouvernementaux. Il fournit et contribue à la détection des tendances et des signaux de sécurité et de l’évaluation de la gestion des risques au cycle de vie du produit. Fournir un soutien sûr aux équipes de développement clinique.

**About the Role**:
Major Accountabilities

~ L’aide est accordée en réponse aux besoins des activités de livraison, c’est-à-dire
~ Aider à surveiller l’innocuité du produit, y compris l’inspection de la documentation, les évaluations médicales/évaluations individuelles des cas ou la détection du signal.
~ Examen de la littérature exécutive
~ Soutien à la préparation d’enquêtes spécifiques pour le ministère de la Santé, en particulier les demandes de notifications à court terme.
~ Suivi du rapport d’évaluation des autorités sanitaires.
~ Aide à l’introduction sécuritaire de questions réglementaires et de documents cliniques. Soutien à l’entretien et à la gestion des anomalies locales
~ Aide à l’évaluation et à la préparation d’autres sorties de sécurité assignées
~ Soutien aux nouvelles lignes directrices de soumission (entrée juridique en matière de sécurité des documents) si nécessaire.
~ Préparez-vous à répondre à une demande de sécurité interne et postez pour répondre à une requête de sécurité externe.
~ Spécialiste des opérations médicales/fonctions médicales (MME)
~ Diriger la formation et l’orientation des membres/collègues subalternes
~ Distribution d’échantillons de commercialisation (le cas échéant)

Key Performance Indicators

Rapidité et qualité de l’analyse, de l’interprétation et de la présentation de la sécurité
Conformité aux réglementations et procédures internes et externes
Conformité aux caractéristiques de sécurité, cohérence et qualité

Work Experience

~Gestion et exécution des opérations
~Gestion de projet
~Collaborer par delà les frontières
~Étendue fonctionnelle
~Défis pour les personnes
~Gérer les crises

**Skills**:
~Recherche clinique
~Sécurité des processus
~Conformité réglementaire
~Équipes fonctionnelles
~Science de la sécurité
~Revue de la littérature
~Dossiers médicaux
~Essais cliniques

Language

Anglais

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

CDI

Shift Work

No

**Accessibility and accommodation**:


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