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Indrykket 07-09-2020

Senior Professional /Global Safety Standards and Compliance/Training Manager

Are you experienced within pharmacovigilance (PV), do you have a passion for training management, and can you support the management of LEOs PV quality documents, then it might be you we are looking for? 

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. If you have experience in quality management, implementation and maintenance of global PV systems in the affiliates, then you may be our new colleague. In Global Safety Standards and Compliance, you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job

In this position your primary focus will be to promote patient and product safety by ensuring robust processes for training in PV procedures, and actively create awareness and understanding of PV regulations through training of the global PV organization and stakeholders across LEO Pharma. In addition, you will support Global Safety quality document management.  

Ensure a robust process across the organisation

  • Responsible for maintaining the PV training as described in GS QMS documents
  • Act as GS superuser of the LEO training system

Manage PV training

  • Design, develop, coordinate and maintain PV training materials reflecting current PV requirements and target audience qualifications
  • Plan and deliver PV training sessions to relevant LEO employees outside the PV organization
  • Lead the PV training of all LEO Pharma employees in HQ
  • Set and maintain global PV training standards and PV training effectiveness measures in alignment with regulatory expectations
  • Support GS subject matter experts in scoping content and setting learning objectives

Support GS Quality Documents Management

  • Contribute to PV quality document writing and maintenance (e.g. Standard Operating Procedures and Work Instructions)
  • Contribute to the maintenance of GS training matrix
  • Responsible for drawing up GS processes in eMap

Your qualifications

  • A scientific educational background or equivalent
  • Strong and well founded experience within the pharmaceutical industry
  • Solid pharmacovigilance knowledge
  • Strong quality mindset
  • Good communication skills
  • Structured and detail oriented
  • Proficient in verbal and written English
  • Good IT skills and experienced user of common Microsoft Office programs

Your new team

This is an interesting job with great opportunities for both personal and professional development. You will be working in an international and cross-disciplinary environment, and you can look forward to becoming part of a dedicated team, who uphold a great working environment. You will be located in Ballerup, and report into the EU QPPV, Head of Global Safety Standards and Compliance.

Join our mission to help more people achieve healthy skin Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow. By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application

If you have questions, please do not hesitate to contact Berit Nautrup Andersen, Director QPPV, at + 45 5379 8853. Please apply via the link at our website and remember to attach application and CV. Send your application to us as soon as possible and no later than 24. Sep 2020 as we’ll be conducting interviews on a continuous basis.

Du må meget gerne skrive i din ansøgning, at du så jobbet på
Industriparken 55
2750 Ballerup
2750 Ballerup
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