Pharmacovigilance audits, PV Specialist – Global Quality

n this role, you will become responsible for performing remote and onsite PV audits of ALK Affiliates, external collaborators, service providers and distributors. You will work as a QA Business Partner with audits and a variety of quality tasks, processes, and systems across multiple GxP areas.

Reporting directly to the Vice President for Global Quality, you will be an essential member of a committed enthusiastic and experienced team, and you will be based at our Head Office in Hørsholm, Denmark. Travelling will be part of your role and you must expect approximately 20 travelling days a year.

Your primary responsibility areas and tasks will be:

• Planning, performing, and reporting of GVP audits.
• Audit CAPA follow up.
• Risk management and tools.
• Supplier management.
• Document Management.
• Conduct stakeholder meetings.

Your profile
You have extensive experience within PV regulated areas, demonstrating a strong understanding of quality management systems and tools, even if you have not served formally as an auditor. Do you have experience with audits as Auditor or participation in audits and inspections it will certainly be an advantage. If you do not have prior experience as an auditor, training will be provided to equip you with the necessary skills.

You hold a B.Sc. or M.Sc. in Health Science and you possess a strong quality mindset, with a consistent commitment to maintaining a high standard in all quality-related processes.

Your personal characteristics:

• Possess high drive and you take initiative and proactive action.
• Ability to work independently, but also being a team player.
• Relation builder working respectfully across different cultures with flexibility.
• Solid cross-cultural communication skills who excel both verbally and written in Danish and English.

Become a part of ALK
We offer an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 23 April 2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net. For further information regarding the position please contact Vice President Global Quality, Siren Jenssen Østerberg 45 50899540.