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Pharmacovigilance and Compliance Manager

1 month ago

Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time
Job Title: PSMF & QPPV Office Manager

About the Role:

We are seeking a highly skilled and experienced PSMF & QPPV Office Manager to join our team at Ascendis Pharma. As a key member of our global PV system, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office. Your primary responsibilities will include maintaining Ascendis Pharma's global PV system, including its quality system, providing oversight and guidance of the QPPV Office operations, and contributing to improvements projects and innovation.

Key Responsibilities:

  • Ensure overall compliance of the PV system and stay up-to-date with legislation, including driving PV intelligence activities.
  • PSMF coordination, preparation, and maintenance with key stakeholders in accordance with assigned schedules and current legislation, including local PSMFs.
  • Oversight and management of deviations and CAPAs.
  • Lead and contribute to the improvements of QPPV and PSMF-related processes and prepare and maintain procedural documents.
  • Support collaboration with vendors and distributors, including contractual agreements (SDEAs).
  • Be part of ensuring inspection readiness.

Requirements:

To be successful in this role, you will need to have a relevant academic degree or similar, such as a Master's degree in a healthcare field, and at least 3 years of experience within pharmacovigilance. You will also need to have solid knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.