Global Program Safety Lead Radiopharmaceuticals
Novartis Farmacéutica, S.A.
Barcelona, Spain
hace 3 horas

Job Description

With 9 marketed products for targeted radioligand therapy and precision radioligand imaging for cancer and other conditions, and a promising development pipeline too, Novartis’ radioligand business is looking for a medical safety lead to join the team of dedicated safety professionals.

This role will help shape the safe profile of our radiopharmaceutical products. We need an experienced safety lead to join us and drive medical safety in new submissions and to advance the benefit-risk profile of our marketed products.

Your responsibilities include, but not limited to :

  • Provides expert safety input to the clinical development program for assigned projects / products, chairs the Safety Management Team, and is 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 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.
  • 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, 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 submissions and responses, in collaboration with other project team members.
  • Minimum requirements

    What you’ll bring to the role :

  • Doctor or higher degree in life sciences or patient care
  • Fluent English (oral and written)
  • Minimum of around >
  • 12 to 15+ years of total career work experience in Pharma, with a large proportion of that in a global role in Medical Safety

  • Oncology experience preferred
  • Experience working cross-functionally and trans-nationally
  • Ability to lead a cross-functional team in a matrix environment.
  • 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.

    Deadline for applications - 31.10.20

    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 : / / / network

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