Medical Safety Expert
hace 1 semana
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.
About the Role:
This role requires close collaboration with the Global Program Safety Lead (GPSL) to ensure optimal patient safety for assigned compounds. You will share responsibility for the integration, analysis, and evaluation of internal and external safety information through product lifecycle management.
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.
Qualifications:
We are looking for a candidate with a 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.
Why Novartis:
At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. If you are passionate about making a difference in the lives of patients and are looking for a challenging and rewarding career opportunity, please submit your application.
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