ALK-Abelló A/S

Pharmacovigilance Auditor

In this exciting position, your quality competencies and experience will come into play as a Lead Auditor within the field of Pharmacovigilance. You will be responsible for performing pharmacovigilance audits of the ALK Headquarter, ALK affiliates, Service Providers and Distributors on your own or in close collaboration with other GVP, GDP and GCP Lead Auditors in ALK. In addition to the auditor role, you will act as Quality Business partner to the Global Pharmacovigilance organization including the QPPV office.

You will be based in our Headquarter in Hørsholm, Denmark within the department Global Quality, Clinical & Markets, an experienced team that work closely with internal and external stakeholders from many different departments, cultures, and countries.

If you enjoy using your professional and personal skills to obtain results together with internal and external stakeholders, this is your next position.

Fields of responsibility

  • Performing pharmacovigilance audits, hereunder planning, execution, reporting and follow up
  • Supplier Management, hereunder qualification of external collaborators, service providers and distributors
  • Evaluation of potential new collaborators in connection to ALKs Growth Strategy
  • Represent and support the Global Pharmacovigilance organisation during regulatory inspections
  • Ensure regulatory surveillance for Pharmacovigilance and impact to the quality and auditing area

Your qualifications

  • M.Sc. within Health Science with 5+ years of experience or
  • B.Sc. within Health Science with 7+ years of experience
  • 5+ years of experience within Pharmacovigilance regulated areas including experience with Quality Management Systems and tools
  • Experience as Lead Auditor within Pharmacovigilance (internal audits of HQ and affiliates and external audits of Distributors and Service Providers)
  • Relation builder working respectfully across different cultures with flexibility.
  • Proactive and take initiative and actively seeks influence and initiate actions on own initiative.
  • Strong cross-cultural communication skills verbally as well as written. Produces written material that is clear, fluent, and easy to understand.

Languages:

  • Danish and English fluent (verbally and written).

Travelling days:

  • Approximately 3-4 travelling days per month worldwide, can be expected.

We offer

ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.

Application deadline

14 May 2021

Contact

For further information on the position please contact Siren Jenssen Østerberg, Senior Director Global Quality Clinical & Markets, phone: 5089 9540.

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Region:
Region Hovedstaden
Region Sjælland
Job type:
Permanent
Working hours:
Full-time
Working days:
Day
Application deadline:
14/05/2021
Location:
Hørsholm
Company homepage:
http://www.alk.net