Medical Safety Expert

hace 4 semanas


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

About the Role:

This position is part of the Medical Safety organization at Novartis Farmacéutica, responsible for ensuring the safety of patients and ensuring optimal patient safety for assigned compounds.

Key Responsibilities:

  • Monitor the clinical safety of projects/products, including literature review, evaluation of individual cases or signal detection, and respond to safety-related questions appropriately.
  • Perform 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.
  • Identify safety signals based on the review of solicited or unsolicited single cases.
  • Perform signal detection, monitoring, and evaluation of all safety signals.
  • Provide inputs into responses to inquiries from regulatory authorities or healthcare professionals on safety issues.
  • Prepare safety data for Health Authority review boards.
  • Provide inputs to responses for legal queries and Country Organization requests involving safety issues.
  • Provide expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
  • Collaborate productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other related departments.
  • Provide safety inputs for clinical and regulatory deliverables, including clinical study protocols, clinical study reports, and investigator brochures.
  • Provide relevant inputs for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed.
  • Provide support as needed for licensing activities, regulatory authority inspections, and project/product recall activities.

Requirements:

  • Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field or Medical Degree (MBBS or MD) required.
  • Medical degree with specialization preferred. Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity.

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