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Sr PV Specialist

 
Requistion ID:  247
Location: 

Copenhagen, N/A, DK

Date:  Mar 14, 2019
 

Senior Specialist, Quality Management Systems and Training – PV Business Support

 

Description

Are you passionate about Pharmacovigilance, Quality Management Systems and Training? Are you motivated by process improvements, project management and seeing the big picture? Would you like the opportunity to take the Lundbeck Pharmacovigilance Quality Management System into the forefront of adding value to the Pharmacovigilance business, patients and regulators? If yes, you may be just the person we are looking for to fill this newly established role.   

 

Our department

As a function within Medical & Regulatory Sciences (MRS), pharmacovigilance is responsible for the safety surveillance and benefit-risk assessment of all Lundbeck’s pharmaceutical products, including pipeline and established products. We presently consist of more than 60 dedicated colleagues who strive to successfully deliver comprehensive safety knowledge in a dynamic and engaged team atmosphere. The PV Business Support Department is a team of 8 specialised Pharmacovigilance professionals responsible for the Lundbeck Pharmacovigilance Quality Management System and training support. The department also provides support to the Lundbeck’s Qualified Person for Pharmacovigilance and local Pharmacovigilance units in affiliates and take responsibility for Pharmacovigilance agreements, compliance monitoring and coordination of audits and inspections.

 

Your job and key responsibilities

You will be overall responsible for our PV QMS and Training strategy, including the further development of both areas. You will always have oversight of our QMS and provide oversight to our management team as needed. You will act as process expert for PV and work closely with line of business on development and maintenance of PV QMS documents, incl. facilitate lean processes and user-friendly documents. You will always have oversight of PV’s training status and ensure maintenance and further development of our intranet site PV Campus and our Learning Management Systems.

 

Your daily work will require close collaboration with colleagues from across PV and MRS. 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/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 ability to find pragmatic solutions and multitasking, often requiring you to proactively reach out to colleagues

 

We offer

This is an excellent opportunity to influence the further development of PV 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 experience with interpretation of European PV legislation, or similar (e.g. US PV legislation, medical device vigilance or similar)
  • Self-driven with strategic mindset and solid understanding of stakeholder management, incl. ability to see different perspectives
  • Lean mindset with solid project management and process mapping skills
  • Solid hands-on experience with management of quality managements systems
  • Relevant scientific education, preferably at MSc level (e.g. pharmacist or similar)
  • Excellent collaboration and communication skills in both English and Danish (oral and written)

 

Further information

For further information, please contact Deputy QPPV & Director Bina Kramhøft Schack on bink@lundbeck.com. Your application and CV should not be sent via email.

We also recommend that you have a look at our website.

 

Your application

Please click on the link below to apply for the job. Applications must be received no later than 22 April 2019

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.