Medical Safety Expert
hace 4 semanas
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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