Associate Director, QPPV Office, Global Affiliate PV Lead

Associate Director, QPPV Office, Global Affiliate PV Lead

Ascendis Pharma

Hellerup, Denmark

Are you passionate about leading Affiliate PV activities, quality processes and patient safety? Do you have experience with incorporating local PV needs into global systems, close involvement with multiple diverse stakeholders and ensuring end-to-end oversight?

If so, now is your chance to join Ascendis Pharma as our new Associate Director, Global Affiliate PV Lead.

We are seeking a passionate colleague to join our growing QPPV Office team. As a key member of the Ascendis Pharma Global Patient Safety team, you will play a crucial role in supporting the oversight of safety activities as well as contributing to the continued growth of our PV system. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the Global Patient Safety (GPS) team consisting of about 20 colleagues, and report directly to the Head of QPPV Office & QPPV, Annemette Boye,who is based in Hellerup, Denmark. You will be based in Hellerup, Denmark with the QPPV Office team.

Your key responsibilities will be:

• Lead global PV oversight for Ascendis Affiliates, ensuring full compliance with local requirements and integration with our global PV system. This includes, but is not limited to:
  • Defining and maintaining global and local PV procedural strategy, including impact assessments and implementation of regulatory requirements and changes;
  • Establish and oversee local literature monitoring, ensuring alignment and quality across global and local teams;
  • Interacting with Affiliates and GPS, ensuring transparent two‑way communication and mutual compliance;
  • Drive PV readiness for product launches across all Affiliates;
  • Lead Affiliate PV audits and inspection activities, coordinating closely with GPS, cross‑functional teams and QA;
  • Oversee Affiliate‑related PV deviations and quality management;
  • Partnering with PV Alliance Management Lead to ensure consistent processes for Affiliates and other markets.
• Lead governance and future strategy for Local PV Responsible Persons (LPPVs), including oversight of compliance and product related activities, vendor contract ownership, performance management/KPI framework development;
• As an integrated part of the QPPV Office, you will also:
  • Support globalization initiatives and business partnerships, when delegated;
  • Support, when applicable, QMS activities, compliance, training and learning oversight related activities to enable the team to succeed;
  • Contribute to the Ascendis PSMF for relevant activities;
  • Provide oversight to and further support the QPPV in the compliant establishment and maintenance of Ascendis Pharma PV system, including its quality and compliance system.

This role requires close, ongoing collaboration with Global Patient Safety teams (especially Vendor Management and ICSR Management teams), Affiliate colleagues, GVP QA, and QPPV Office stakeholders.

Qualifications and Skills:

You hold a relevant degree in the life sciences area and 7+ years of experience within post-marketing pharmacovigilance and quality processes.

Furthermore, you have:

• Solid experience with Affiliate PV system(s), preferably both from local and global perspective;
• Strong and broad knowledge in EU GVP legislation, FDA and other major regulatory authority PV requirements;
• Experience with “translating” regulatory requirements into quality processes, including ensuring efficient implementation at a local level;
• Proficiency in English at a professional level, both written and spoken, and you master MS Office. Solid experience with Veeva systems is an advantage.

Key competencies:

• You are a strong team player and have a can-do attitude. You bring a positive mindset and see challenges as opportunities;
• You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key;
• To succeed in this role, we also expect you to be self-driven, work independently and have strong communications skills;
• Furthermore, the position requires flexibility and the ability to work some overlapping hours with colleagues based in Palo Alto, California.