Safety Labeling Manager CDS&SD (m/w/d)

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Division Global Drug Development
Geschäftseinheit CMO & PATIENT SAFETY GDD
Standort Holzkirchen (bei München)
Funktionsbereich Forschung & Entwicklung
Art der Stelle Vollzeit
Anstellungsverhältnis Unbefristet
StellenID 277491BR


Stellenbeschreibung

3000! That’s how many safety signals have been detected and medically evaluated in one year, requiring 300 CDS reviews and update packages. The Safety Labeling Manager CDS&SD task is to systematically detect and evaluate Safety Signals for assigned products from various sources, and to keep the Core Data Sheet database / Integrated Product List (IPL), as well as the Core Safety Information / Core Dates Sheet of assigned products up-to-date with current scientific knowledge as per applicable procedures, including responding to Health Authority and/or internal questions on any of these documents.

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:
• Performs tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs), including tasks assigned in harmonized GOPs/SOPs/WIs as per the role mapping in the applicable role matrix.
• Provides timely and adequate updates of the core safety information, supported by expert statements and commented track change versions of the CDS.
• Prepares data packages required by 3rd party providers. Reviews and qualifies CDSs deliveries from providers; creates new CDS as needed.
• Ensures patient safety through timely and adequate updates of the core safety information of marketed products.
• Tracks signals in the signal management tracking system, and evaluates line listings and safety information in scientific literature, including reference product information and regulatory authority communication.
• Presents safety issues to the Safety Management Board / other internal boards as needed.
• Trains and develops / coaches new colleagues (internal and/or external) supporting the CDS team.



Mindestanforderungen

What you’ll bring to the role:
• Health-Care Professional – Physician or Pharmacist
• Fluent English in writing and speaking
• At least 4 years PV or label experience and regulatory
• Considers HA + internal stakeholder input appropriately

Desirable Requirements:
• Health-Care Professional with MD, PhD

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.


Sandoz 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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