Job opportunities

CQA Specialist, Pharmacovigilance

Location

Region Hovedstaden

City

Copenhagen

Department

Research and Development

Application deadline

05 January 2018

Description

Description
Are you fascinated by the intricacies and complexities that make up of a global PV system?  Are you motivated by a quality mindset and building quality into processes? If yes, you may be just the person we are looking for to fill this position.  
CQA is responsible for the independent global audit programmes of the entire pharmacovigilance system. The CQA function consists of 10 highly motivated and dedicated colleagues, collaborating closely with our stakeholders worldwide, to promote a quality mindset and maintain compliance throughout the PV business processes and System. We are part of the R&D organisation at Lundbeck.
The position will be based at our headquarters in Valby.

Your job and key responsibilities
Reporting to the Senior Director, Head of CQA, you will be responsible for execution of the PV audit strategy, including delivery of a risk based audit programme covering the quality and compliance of the PV System. You are also responsible to provide input and advice on processes and areas impacted by Good Pharmacovigilance Practice (GVP) with respect to the requirements of global and local regulations, guidelines and industry best practices. This position has no line management responsibilities, but you will be a vital contributor to our inspiring patient focussed strategy.  

Your main responsibilities will be to:

  • Proactively participate in the development of the risk based PV audit programmes.
  • Independently plan and conduct PV audits and audit series of various complexities, in line with the PV risk based audit programme.
  • Lead the preparation, hosting and follow up of Regulatory Authorities inspections related to clinical safety and Pharmacovigilance activities at Lundbeck hubs, and lead or assist at Affiliate inspections as deemed necessary and practicable.
  • Support the provision of QA support for validation of pharmacovigilance related computerized systems.
  • Contribute to providing data for Key Quality/Performance Indicators and quality compliance status.
  • Manage external auditors as required, ensuring that findings from relevant audits are distributed, and responses and CAPAs are tracked and followed up as necessary in the CAPA system.
  • Perform as needed, other tasks within your competence, as determined by relevant training, experience and/or qualifications.

Some travel is expected, periodically up to 35%.

We offer
We offer you an interesting and challenging job working in a dynamic and culturally diverse global team, where everyone matters. You will have the opportunity to influence and inspire the PV audit processes and interfaces, including how CQA support the line of business in providing metrics, trending and advising on requirements for validation and maintenance of PV related computerised systems. You will have global responsibilities and will collaborate with many different stakeholders across R&D and business partners.  Your role is essential in preparing us for the future and we are eagerly looking forward to receiving your application.

Qualifications
Our preferred candidate has the following professional and personal qualifications: 

  • University/Bachelors degree or local equivalent in life sciences, nursing or equivalent degree/experience. A higher degree (MSc or PhD in life sciences or quality management related topics) is an asset.
  • Broad-ranging experience in the pharmaceutical industry, including significant time working in Pharmacovigilance-related quality assurance area and in the conduct of the full range of pharmacovigilance audits.
  • In depth knowledge and understanding of Pharmacovigilance systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GVP principles, and practices. Able to apply theoretical knowledge in practical situations. Knowledge of biologics would be an advantage.
  • Able to takes responsibility for own work, highly reliable, with a positive approach, even under times of pressure; ability to manage own workload, set priorities within the remit allocated by management.
  • Confident negotiator, able to influence and gain collaboration from colleagues, business partners and other stakeholders across cultural barriers, including senior management during the audit process.
  • High degree of fluency in both written and spoken English. Additional language skills would be an advantage.

Further information
For further information, please contact Andria Wilk on AER@lundbeck.com or +45 30 83 50 99. 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 05 January 2018.

 

Apply for the job here

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Lundbeck is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.

An estimated 700 million people worldwide are living with psychiatric and neurological disorders 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 psychiatric and neurological disorders – we call this Progress in Mind.

Read more at http://www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated revenue of DKK 14.6 billion in 2015 (EUR 2 billion; USD 2.2 billion).

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

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