Job details
Job type full-time
Full job description
769 millionThat’s how many lives our products touched in 2020And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide, and was one of the first pharmaceutical companies to pioneer car-t research and initiate global car-t trialsNovartis has a strong car-t pipeline and ongoing investment in manufacturing and supply chain process improvementsWith active research underway to broaden the impact of cell and gene therapy in oncology, novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation car-t cell therapies that focus on new targets and utilize new technologies.
**this position can be based remotely anywhere in the u.s(there may be some exceptions based on legal entity registration)Please note that this role would not provide relocation as a resultThe expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.**
Your responsibilities include, but are not limited to:
Provide 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)
Responsible for safety issue management from formation of global program team (gpt) through life cycle management.
Develops and is responsible for key internal novartis safety documents: reviews these documents regularly and updates as required
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
Responsible for initial development and ongoing maintenance of safety information in core data sheet (core global labeling), including addressing safety issues effectively in all project/product labeling indications
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
Eeo statement
The novartis group of companies are equal opportunity employers and take pride in maintaining a diverse environmentWe do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected statusWe are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Minimum requirements
What you`ll bring to the role:
Medical degree (md) or equivalent required
3 years clinical experience postdoctoral
5 years drug development experience in a major pharmaceutical company (of which 2 years should be in a global position); including 2 years in safety at an operational or medical position
Experience in scientific analysis, clinical safety assessments and regulatory discussions on safety and risk management
Prior experience of leading cross-functional, multi-cultural teams
Experience in leading cross-functional, multi-cultural teams and of (safety or others) issue management
Why consider novartis?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environmentWhere you’re given opportunities to explore the power of digital and dataWhere you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at novartis!
Commitment to diversity & inclusion:
Novartis embraces diversity, equal opportunity and inclusionWe are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our novartis network: if this role is not suitable to your experience or career goals but you wish to stay connected to learn more about novartis and our career opportunities, join the
Novartis network here: https://talentnetwork.novartis.com/network
Division
Global drug development
Business unit
Cmo & patient safety gdd
Country
Usa
Work location
East hanover, nj
Company/legal entity
Novartis pharmaceuticals
Functional area
Research & development
Job type
Full time
Employment type
Regular
Shift work
No
Early talent
No
