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Principal Professional / Specialist, PV Quality Management System

 
Requistion ID:  1250
Location: 

Copenhagen, N/A, DK

Date: 
 

Principal Professional / Specialist, PV Quality Management System – GPS Business Support

Are you passionate about pharmacovigilance and making a difference for Patient Safety? Are you motivated by process mapping, writing and managing SOPs? Do you have profound ability to “connect the dots” and coordinate across? Are you an expert in pharmacovigilance processes with a strong drive to build innovative QMS documents? If yes, you may be just the person we are looking for.

 

As a function within Research & Development, Global Patient Safety (GPS) is responsible for the safety data management, surveillance and benefit-risk assessment of all Lundbeck’s pharmaceutical products, including pipeline and established products. We consist of more than 100 dedicated colleagues who strive to successfully deliver comprehensive safety knowledge working together in a dynamic, diverse global team across Denmark, Singapore and the US.

The GPS Business Support department is a team of 9 specialised pharmacovigilance professionals responsible for the GPS Quality Management System. The department is also responsible for the Lundbeck QPPV Office, and the GPS training support, and further provides support to local Patient Safety units in affiliates and take responsibility for Pharmacovigilance agreements.

Your job and key responsibilities

You will be overall responsible for managing the PV QMS, including supporting the Line of Business and the GPS Leadership Team in ensuring that the QMS is complete and without gaps, and compliant with current global regulatory requirements. You will support GPS staff in the development and maintenance of steering documents to ensure lean, innovative user-friendly QMS documents. Further, you will have continuous oversight of the QMS and coordinate and manage periodic reviews, deviations and SOP training compliance.

 

Your daily work will require close collaboration with colleagues from across GPS Business Support and the rest of GPS. You will also collaborate with stakeholders from other parts of the R&D organisation, affiliates and service providers. You will represent PV in various Process Owners and Process Oversight fora.

You will work in an international environment, where all communication is in English. The job requires diligence and attention to details while at the same time the ability to find creative and yet pragmatic solutions and proactivity in reaching out to process experts across the organization.  

We offer

This is an excellent opportunity to influence the further development of Patient Safety in Lundbeck, and we offer an interesting job in an ever more demanding area of the pharmaceutical industry in a global environment, with attractive and flexible working conditions and good career opportunities.

 

Qualifications

Our preferred candidate has the following personal and professional qualifications:

  • Solid hands-on experience with management of quality managements systems
  • Solid hands-on experience with interpretation of EU and international pharmacovigilance regulatory requirements, and translating these into processes
  • Lean mindset with creativity, proactivity and excellent process mapping skills
  • Self-driven with solid quality mindset and attention to details
  • Project management skills with good understanding of stakeholder management, incl. ability to see different perspectives
  • Excellent collaboration and communication skills in English (oral and written)
  • Relevant scientific education, preferably at MSc level (e.g. pharmacist or similar)

Further information

For further information, please contact Bina Kramhøft Schack at bink@lundbeck.com.

Your application and CV should not be sent via email.

We also recommend that you have a look at our website, LinkedIn and Instagram.

 

Your application

Please click on the apply button. Applications must be received no later than August 10th 2020. 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.


An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.