Systems & Applications Manager

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Indrykket: 2.9.2020

ALK-Abelló Nordic A/S, Hørsholm

Do you like IT systems, validation, documentation and lots of contact to Line-of-Business? Then you might be our new colleague.

Global Pharmacovigilance & Clinical Development (GPCD) is looking for a Systems & Applications Manager to join the Systems & Applications Team. An exciting job with a high degree of individual responsibility in a dynamic atmosphere is waiting for the right candidate.

About the department

The Systems & Applications Team is part of the Global Pharmacovigilance & Clinical Development area and has a supporting role to both Pharmacovigilance and Clinical Development. The team consists of four engaged colleagues located in Hørsholm, Denmark. The department is responsible for the maintenance, development and continuous improvement of the GxP and Non-GxP IT systems used in GPCD.

These include the Global Safety Database, CTMS system and BI-Tools. In addition, the department is also assisting in cross organisational projects as well as projects with external partners.

Apart from our stakeholders, the System & Application team work closely together with our Quality Assurance Department and the Global IT Department (GBIT).

The department works in an informal, fast-paced atmosphere with multiple global stakeholders across ALK, reflecting the increasing demands from clinical trials and regulatory authority requirements.

The position

Using your knowledge and experience, your main responsibility is to contribute to the maintenance, development and continuous improvements of the GPCD IT systems to ensure functionality and compliance.

You will be expected to independently manage and drive GPCD IT projects, from initiation to hand over, to Line-of-Business.

You will participate in implementation of changes to existing systems and/or initiation (implementation) of new systems. You will give subject matter expert input regarding regulatory requirements, business processes and validation requirements. You will be included in all levels of the projects, from project management to documentation of informal and formal testing.

You will also update standard operating procedures and guidelines, support and train of end-users and act as a point of entry to the Global IT Department.

Your qualifications

  • B.Sc. or M.Sc. within natural science or similar
  • Minimum 4-5 years of experience within Clinical or Pharmacovigilance regulated areas
  • Ability to independently manage and drive projects
  • A team-player with good analytical skills and a quality-oriented mindset
  • Ability to understand various stakeholder needs whilst maintaining objectivity
  • Experience working with safety or clinical databases


You are experienced with IT system testing, validation requirements and documentation, impact assessment and stakeholder management.

The role requires a structured approach and strong analytical skills including the ability to focus on details and adherence to standards, while maintaining a balanced business perspective. The capability to understand and connect regulatory requirements, business processes and functionality of IT systems is essential.

You show initiative, are flexible and have a good sense of humour. You are open-minded, enthusiastic and a strong team-player. You are fluent in both written and spoken English on a professional level and feel comfortable working with colleagues from different cultural backgrounds.

Allergy Solutions for Life

More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.

By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.

We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.

By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.

Application deadline

If this sounds like a mission you also would like to be part of, we hope to receive your CV and application no later than 18 September, 2020.

The application should be in English.

Contact

For further information please contact Michael Kristensen, Head of GPCD Systems & Applications at +45 50 89 95 71.
ALK er specialiseret inden for allergivaccination – en unik behandling som ikke bare reducerer symptomerne, men også behandler den underliggende årsag til allergien.

Som verdensledende inden for allergivaccination arbejder vi på at forbedre livskvaliteten for alle de allergikere, hvis sygdom stadig ikke er under kontrol til trods for, at de tager symptomlindrende allergimedicin. Det gør vi ved at udvikle produkter som giver langvarig effekt.

ALK tilbyder produkter til allergivaccination i form af injektioner og tabletter, hvor tabletterne er den nyeste, mest veldokumenterede og enkleste behandlingsform.