Novartis

Global Program Safety Lead, Spain

2 weeks agoBarcelona, Spain

Job Description

More than 52 different medical diseases! Novartis Global Drug Development portfolio includes a large number of innovative platform studies with more than 90 projects in clinical development, of which this safety position will play a key leadership role in supporting patient safety for breakthrough innovative immuno-oncology medicines.

Your responsibilities include, but not limited to:
• 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.
• Develops and is responsible for key internal Novartis safety documents: reviews these documents regularly and updates as required
• 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 initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications.
• Is responsible and leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

Minimum Requirements

What you'll bring to the role:
• Medical Doctor or higher degree in life sciences
• Fluent English (oral and written)
• 3-4 years relevant experience
• Experience working cross-functionally and trans-nationally
• Oncology experience preferred, but not required.

You'll receive:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And 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?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where 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!

We kindly ask you to apply with an English version of your CV and if shortlisted you can expect a call from an international number.

Novartis embraces diversity, equal opportunity and inclusion. We 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

Location
Spain

Site
Barcelona

Company / Legal Entity
Novartis Farmacéutica, S.A.

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Job ID: Novartis-313155BR