Manager Safety Risk Management, Novartis, Germany

Division Global Drug Development
Geschäftseinheit CMO & PATIENT SAFETY GDD
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 230522BR


Stellenbeschreibung

Manager Safety Risk Management, Novartis, Germany.

Job Summary

Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives?
Look no further, apply today. Manager Safety Risk Management, Novartis, Holzkirchen, Germany. This position can be opened in different multiple locations: Spain, Basel (Switzerland) or Hyderabad (India)

Novartis is currently recruiting for a Manager Safety Risk Management to join our Global Drug Development Division to do preparation, proofreading and updates of documents required for Safety Risk Management in an international and dynamic environment.

Job purpose

The purpose of the Manager Safety Risk Management role is to be responsible for in particular Risk Management Plans, Medical Risk Assessments for Product Quality Investigations and Signal Detection & Evaluations for assigned products (“Generics” & “Biosimilars”)

Key Responsibilities

• Perform tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs)
• Preparation of RMPs and/or MRAs according to legal requirements and internal procedures.
• Medical Review of RMPs and/or MRAs prepared by colleagues.
• Handling of Assessment Reports and Health Authority feedback; questions and preparation of answers to Health Authorities.
• Preparation and review of working instructions.
• Proofreading of RMPs and MRAs prepared by external service providers, preparation of feedbacks and quality metrics.
• Presents safety issues to the Safety Management Board.
• Evaluation of Signals and Issues as per internal procedures.

About Novartis:

Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. In Novartis Group we focus on three areas – innovative medicines (Pharmaceuticals & Oncology), eye care (Alcon) and generics (Sandoz).
With our 26 000-plus employees in more than 140 countries, we discover new ways to improve and extend people’s lives.

Our mission is to discover new ways to improve and extend people's lives. Our vision is to be a trusted leader in changing the practice of medicine. Corporate responsibility is central to how we run our business. We focus our CR work in two key areas: expanding access to healthcare and doing business responsibly.
As a global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.

Our culture is defined by our values: innovation, quality, collaboration, performance, courage, integrity.

Benefits of Working for Novartis

• Competitive salary
• Performance based annual bonus
• Work/life balance
• Additional holiday allowance
• Eligible to company's pension plan
• 30 working days' holiday per calendar year
• Subsidised on-site cafeteria
• Free shuttle bus between office and Holzkirchen train station
• Additional benefits

‘I came for the job, I stay for the culture’

#LI-NOV



Research & Development


Mindestanforderungen

The ideal candidate will have

• Higher education, such as Health-Care Professional Desirable: Physician with PhD (Dr. med.; MD, PhD)
• 4 years PV experience
• Fluent in English
• Work experience in a multinational company is a plus
• Highly developed organisational skills and sound organizational understanding and ability to work with a diverse workforce
• Strong verbal and written communication skills
• Proven ability to communicate and collaborate effectively across a global organization
• Adaptability and ability to work under pressure

We focus on creating an inclusive organisation and welcome people who have different knowledge, perspectives, experience and working styles from across the global population.



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