Global Program Safety Lead (m/w/d)

Division Global Drug Development
Geschäftseinheit CMO & PATIENT SAFETY GDD
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 267926BR


The purpose of Global Program Safety Lead is to serve as scientific safety leader of the Medical Safety organization to improve patients’ lives and impact on overall Novartis results through robust safety evaluation expertise and medical innovation.

Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives? Join Sandoz!

A division of Novartis, Sandoz is a global leader in Generic and Biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.

Your responsibilities:

• Provides expert safety input to the clinical development program
• Develops & is responsible for key internal NVS safety documents
• Owns the safety strategy & document it in the corresponding documents & leads the production of the med safety deliverables for the assigned products
• Is responsible for overall signal detection, monitoring, evaluation, interpretation & appropriate mgt of safety info
• Is responsible for initial development & ongoing maintenance of safety info in Core Data Sheet, including addressing safety issues in all project/product labeling indications


Research & Development


What you’ll bring to the role:

• Timeliness and quality of safety analysis, interpretations, presentations and communication
• Compliance with internal SOPs/WPs and external regulations

Desirable Requirements:

• Med Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required
• Specialty Board certification desirable
• Fluent in spoken and written English
• Understanding in another major language (e.g. French, German, Spanish) desirable
• 3 years clinical experience postdoctoral
• At least 5 years in drug development in a Major, pharmaceutical company (of which 2 years in a global, position), including 2 years in safety at an operational, or medical position
• Experience in preparing or contributing to preparation, of clinical safety assessments and regulatory reports/ submissions involving safety Information
• Experience in leading cross-functional, multi-cultural Teams
• Experience with (safety or others) issue Management, Experience in drug development, clinical Trial, methodology, regulatory requirements, scientific, methodology, statistics and writing of publications

You’ll receive: (optional)
• Competitive salary
• Performance based annual bonus
• Work/life integration
• Eligible to Sandoz pension plan
• 30 working days' holiday per calendar year
• Subsidised on-site cafeteria
• Free shuttle bus between Sandoz and Holzkirchen train station
• Additional benefits

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us, and help reimagine access to medicine.

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.

Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

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