Pharmacovigilance Specialist to the EU-QPPV Office

3 days ago


Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

About ALK

ALK is a global pharmaceutical company specializing in allergy immunotherapy.

We strive for high professionalism, integrity, and an open-minded approach in creating an inspiring and fun working environment together with our colleagues.

We provide an attractive working environment for individuals seeking personal and professional growth.

You will be part of an engaged and informal team that values skill and knowledge creation.

Job Description

We seek an experienced Pharmacovigilance (PV) Specialist to join our QPPV Office as a key member of our team.

Your primary responsibility will be managing and overseeing our global PV regulatory intelligence function.

This entails assessing and interpreting new legislation and guidelines, ensuring their effective implementation to enhance value for our patients and for ALK.

In addition to your primary role, you will lead or contribute to various ad hoc tasks, including:

  • PV Deviation Management
    • Conducting root cause analyses, criticality assessments, and developing corrective and preventive actions (CAPAs).
  • PV Supplier Management
    • Serving as the primary contact for our preferred PV suppliers, ensuring up-to-date PV Agreements, and monitoring performance according to defined metrics.
  • PV System Implementation and Maintenance
    • Assisting affiliates and commercial partners with implementing and maintaining local PV system master files.
    • Ensuring local QPPVs have access to relevant global data necessary to fulfill their responsibilities.
  • Audit and Inspection Coordination
    • Coordinating and managing audits and inspections to ensure compliance with established standards.

You will work independently and collaboratively with colleagues in the QPPV Office and across functional areas at ALK.

This role carries significant responsibility, providing opportunities for professional growth and making a personal impact within the organization.



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