Senior Pharmacovigilance and Compliance Manager

2 months ago


Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time
About the Role

We are seeking a highly skilled Senior Pharmacovigilance and Compliance Manager to join our growing team at Ascendis Pharma A/S. As a key member of our Pharmacovigilance and Compliance Department, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office, supporting the QPPV and deputy QPPV in maintaining our global PV system, and contributing to improvements projects and innovation.

About the Company

Ascendis Pharma A/S is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Key Responsibilities
  • Evaluate and maintain overall compliance of the PV system, staying up-to-date with legislation, including driving PV intelligence activities
  • Coordinate, prepare, and maintain PSMF (Periodic Safety Update Report) documents with key stakeholders in accordance with assigned schedules and current legislation, including local PSMFs
  • Oversight and management of deviations and CAPAs (Corrective Action Preventive Actions)
  • Lead and contribute to the improvement of QPPV and PSMF-related processes, preparing and maintaining procedural documents
  • Support collaboration with vendors and distributors, including contractual agreements (SDEAs - Standing Data Exchange Agreements)
  • Ensure inspection readiness
Requirements and Qualifications

To succeed in this role, you should have:

  • A relevant academic degree or similar (e.g., Master's within a healthcare field), with at least 3 years of experience within pharmacovigilance
  • Solid knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents
  • Experience with managing EEA and UK PSMFs
  • Ability to identify and implement process improvements
  • Ability to work on multiple simultaneous tasks with limited supervision
Competencies

You are a strong team player but also thrive in solving tasks independently. You work systematically, with an eye for details, and have a can-do attitude. You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

Responsibilities include ensuring quality in your work, prioritizing tasks, building relationships even at a distance, having good communication skills, both written and verbal, and willingness to travel (approximately 10-15 days per year).

About the Location

This position is based in Hellerup, Denmark, and reports directly to Eva Widebæk Rasmussen, Sr. Director & QPPV. For more information about the company, please visit our website.



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