Medical Safety Lead Consultant

hace 3 semanas


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

Medical Safety Lead Role Overview

Novartis Farmacéutica is seeking a Medical Safety Lead to provide robust safety evaluation expertise and medical innovation to improve patients' lives and impact overall results. As a member of the Medical Safety organization, the position prioritizes the safety of patients, ensures optimal patient safety for assigned compounds, and shares responsibility for the integration, analysis, and evaluation of internal and external safety information through product lifecycle management.

About the Role

This position is open for collaboration with the Global Program Safety Lead (GPSL) and involves monitoring the clinical safety of projects/products, including activities such as literature review, evaluation of individual cases or signal detection, and responding to safety-related questions appropriately.

Main Responsibilities

  • Monitors the clinical safety of projects/products, including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety-related questions appropriately.
  • Performs medical assessment and related activities for cases whenever required, including collecting additional follow-up information, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees.
  • Identifies safety signals based on the review of solicited or unsolicited single cases.
  • Performs signal detection, monitoring, and evaluation of all safety signals.
  • Provides inputs into responses to inquiries from regulatory authorities or healthcare professionals on safety issues.

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