Summary
About the Role
- Provides expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT) -Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
- Is responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources.
- Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities.
- Is responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues.
- Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members -Contributes to and often leads the development of departmental and functional/business unit goals and objectives.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
- Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations & procedures -Compliance, consistency and quality of safety deliverables
Work Experience:
- People Challenges.
- Managing Crises.
- Collaborating across boundaries.
- Operations Management and Execution.
- People Leadership.
- Clinical Research.
- Clinical Trials.
- Functional Teams.
- Leadership.
- Medical Strategy.
- Process Safety Management.
- Regulatory Compliance.
- Risk Management.
- Safety Science.
- English.
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
