Experienced PV Specialist to the QPPV Office

Do you have a passion for pharmacovigilance (PV)? Do you want to support the EU QPPV in maintaining oversight of the PV system? Would you like to join a team of highly engaged PV Specialists committed to building an outstanding, inclusive, and engaging working environment?

If you have the experience to add an extra dimension to our team and find the above challenges exciting and inspiring, then you may be our new colleague.

The position
As PV Specialist you will join the QPPV Office, which is part of Global Safety & Pharmacovigilance based at ALK´s headquarter in Hørsholm, Denmark. As a key member of our team, you will play a central role in the responsibilities belonging to the QPPV Office.

Your primary responsibility will be managing and overseeing our global PV regulatory intelligence function. This entails assessing and interpreting new legislation and guidelines and ensuring their effective implementation to enhance value for our patients and for ALK.

In addition to your primary role, you will also lead or contribute to a variety of ad hoc tasks, including:

• Managing and supporting the organization in addressing PV deviations, including conducting root cause analyses, criticality assessments, and the development of corrective and preventive actions (CAPAs).
• Serving as the primary contact for our preferred PV suppliers, ensuring that PV Agreements are up to date, and their performance is monitored according to defined metrics.
• Assisting our affiliates and commercial partners with the implementation and maintenance of local PV system master files, while ensuring local QPPVs have access to the relevant global data necessary to fulfill their responsibilities.
• Coordinating and managing audits and inspections to ensure compliance with our established standards.

You will work both independently and collaboratively with colleagues in the QPPV Office and colleagues across various functional areas at ALK. This role carries significant responsibility, providing an opportunity for professional growth and the ability to make a personal impact within the organization.

The position reports directly to the Head of the QPPV Office, EU-QPPV.

Your profile
We imagine that you bring:

• A master’s or bachelor’s degree in related life science field.
  • A robust theoretical foundation coupled with practical experience in PV and a strong focus on quality aspects. This includes comprehensive knowledge of international PV regulations and guidelines.
  • A strong analytical mindset and a structured approach to problem-solving.
  • Excellent written and verbal communication skills.
  • Proficiency in Microsoft Office applications, particularly MS Word and MS Excel.
  • Fluency in both spoken and written English.

Moreover, you have the following personal skills:

• Ability to work independently as well as collaboratively with team members and stakeholders.
  • An open-minded attitude and a willingness to consider diverse opinions.
  • An innovative, proactive, result-oriented, and goal-driven mindset.
  • Strong negotiation and relationship-building skills.
  • A genuine passion for PV and intrinsic motivation to make a meaningful impact.

Become a part of ALK
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. We provide an attractive working environment for individuals looking for both personal and professional development. You will be part of an engaged and informal team who values skill and knowledge creation.

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. Do you want to learn more about our company, we encourage you to visit us at www.alk.net.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 23^rd of March 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.

If you have questions regarding the position, please contact Klaus Bitsch-Jensen, Head of QPPV Office & EU-QPPV by telephone +45 41 95 90 30.

We look forward to hearing from you!