摘要
About the Role
Major accountabilities:
- Monitors the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety related questions appropriately .
- Performs 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.
- Identifies safety signals based on the review of solicited or unsolicited single cases.
- Performs signal detection, monitoring and evaluation of all safety signals.
- Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.
- Prepares safety data for Health Authority review boards.
- Provides inputs to responses for legal queries and Country Organization requests involving safety issues.
- Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
- Collaborates 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.
- Contributes to the development of departmental goals and objectives.
- Distribution of marketing samples (where applicable)
Key performance indicators:
- Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency and quality of safety deliverables
Minimum Requirements:
Work Experience:
- People Challenges.
- Critical Negotiations.
- People Leadership.
- Collaborating across boundaries.
- Operations Management and Execution.
Skills:
- Clinical Trials.
- Functional Teams.
- Literature Review.
- Management Skills.
- Medical Information.
- Medical Records.
- Medical Strategy.
- Pharmacovigilance.
- Regulatory Compliance.
- Risk Management.
- Safety Science.
Languages :
- 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
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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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
