Medical Safety Expert

hace 1 mes


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.

The Medical Safety Lead will provide robust safety evaluation expertise and medical innovation to improve patients' lives and impact overall Novartis results.

Key responsibilities include:

  • Monitoring the clinical safety of projects/products, including literature review, evaluation of individual cases or signal detection, and responding to safety-related questions.
  • Performing 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.
  • Identifying safety signals based on the review of solicited or unsolicited single cases.
  • Performing signal detection, monitoring, and evaluation of all safety signals.
  • Providing inputs into responses to inquiries from regulatory authorities or healthcare professionals on safety issues.
  • Preparing safety data for Health Authority review boards.
  • Providing inputs to responses for legal queries and Country Organization requests involving safety issues.
  • Providing expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
  • Collaborating 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.
  • Providing safety inputs for clinical and regulatory deliverables, including clinical study protocols, clinical study reports, and investigator brochures.
  • Providing relevant inputs for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed.
  • Providing support as needed for licensing activities, regulatory authority inspections, and project/product recall activities.

Qualifications:

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.

Relevant experience (e.g., clinical, postdoctoral) after graduation.



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