Medical Safety Lead
hace 2 semanas
Medical Safety Lead
Job Summary:We are seeking a highly skilled Medical Safety Lead to join our team at Novartis. As a key member of our Medical Safety organization, you will be responsible for providing robust safety evaluation expertise and medical innovation to improve patients' lives and impact overall Novartis results.
Key Responsibilities:- Monitor the clinical safety of projects/products, including activities such as 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.
- 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.
- Relevant experience (e.g., clinical, postdoctoral) after graduation.
- At least 12 years in drug development in a major pharmaceutical company, including 6 years in patient safety at an operational or medical position (or equivalent experience) is desirable.
- Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and writing of publications.
- Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.
- Experience in preparing or contributing to the preparation of clinical safety assessments and regulatory reports involving safety information.
- Experience with safety or other issue management.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
We are an equal opportunities employer and welcome applications from all qualified candidates.
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