Associate Director, Deputy QPPV

Associate Director, Deputy QPPV

Ascendis Pharma

Hellerup, Denmark

Description

Are you passionate about quality processes and patient safety? Do you have experience within Pharmacovigilance and the QPPV role/QPPV office related activities?

If so, now is your chance to join Ascendis Pharma as our new Associate Director, deputy QPPV.

We are seeking a passionate deputy QPPV to join our growing 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 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 also be based in Hellerup, Denmark with the QPPV Office team.

Your key responsibilities will be

• In the absence of the QPPV and, as delegated, to take on the role and responsibilities of the QPPV, incl. acting as a single PV contact point for the competent authorities in the EEA and the UK on a 24‑hour basis;
• Support the QPPV in the compliant establishment and maintenance of Ascendis Pharma PV system, including its quality and compliance system;
• Serve as the process owner for the Global Patient Safety regulatory intelligence process, incl. implementing improvements;
• Support the establishment and maintenance of Safety Data Exchange Agreements (SDEAs) and PV Agreements with Business Partners/Alliance partners, incl. the implementation of SDEA deliverables;
• As part of the QPPV Office team, support, when applicable, in QMS, compliance, training oversight and PSMF related activities to enable the team to succeed as a whole.

Qualifications and Skills

You hold a relevant academic degree in the life sciences area and 5+ years of experience within pharmacovigilance (pre- and post-marketing), and quality processes.

Furthermore, you have:

• Proficiency in English at a professional level, both written and spoken, and you master MS Office. Solid experience with Veeva systems is an advantage;
• Strong and broad knowledge in EU GVP legislation, FDA and other major regulatory authority PV requirements;
• Experience with “translating” regulatory requirements into quality processes;
• Experience or exposure to managing PV Agreements/SDEAs, specifically in the post-marketing area.

Key competencies:

• You are a strong team player, analytical, 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.