PSMF & QPPV Compliance Manager

3 weeks ago


Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time
Role Overview

At Ascendis Pharma, we are seeking an experienced and skilled QPPV Office Manager to join our team. In this role, you will be responsible for ensuring the day-to-day operations of the QPPV Office, supporting the QPPV and deputy QPPV in maintaining our global PV system, including its quality system.

As a key member of our team, you will contribute to improvements projects and innovation, maintain the PSMF, and provide PSMF-related subject matter expertise. You will be part of a fast-paced environment, collaborating with cross-functional global teams to achieve extraordinary results.

Key Responsibilities
  • Ensure overall compliance of the PV system and stay up-to-date with legislation.
  • Manage PSMF coordination, preparation, and maintenance with key stakeholders.
  • Oversight and management of deviations and CAPAs.
  • Lead and contribute to the improvements of QPPV and PSMF-related processes.
  • Support collaboration with vendors and distributors, including contractual agreements.
  • Ensure inspection readiness.
Requirements

You must have a relevant academic degree or similar, at least 3 years of experience within pharmacovigilance, and solid knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents.

Additionally, you must have experience with managing the EEA and UK PSMF, ability to identify and implement process improvements, and ability to work on multiple simultaneous tasks with limited supervision.



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