Medical Safety Lead - Oncology
About this role
Summary
At Novartis, we are dedicated to medical innovation and safety evaluation to ensure the well-being of those we serve. As a key member of our Medical Safety organization, you will collaborate closely with the Global Program Safety Lead (GPSL) to provide robust safety expertise and drive medical advancements.
About the Role
Novartis is not able to offer relocation support for this role. Please only apply if this location is accessible for you.
Major accountabilities:
- Monitoring 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 effectively.
- Perform medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, 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. Performing signal detection, monitoring and evaluation of all safety signals.
- Contributing towards responses to inquiries from regulatory authorities or health care 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.
- Collaborate efficiently on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
- Contribute to the development of departmental goals and objectives.
Minimum Requirements:
- At least 4 years in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position (or equivalent experience) .
- Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications is desirable.
- Proven ability to analyze, interpret, discuss, and present safety information
- Experience in preparing or contributing to preparation of clinical safety. assessments and regulatory reports involving safety information
Education:
- Medical Degree preferred.
- Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field can also be considered for candidates with more extensive experience in patient safety.
Skills:
- Risk Management.
- Safety Science.
- Clinical Trials.
- Functional Teams.
- Literature Review.
- Medical Strategy.
- Pharmacovigilance.
- Regulatory Compliance.
- Medical Information.
- Medical Records.
Languages :
- Fluent English (both spoken and written) is required.
- Additional languages are an advantage.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.