EU QPPV, Head of QPPV Office

EU QPPV, Head of QPPV Office

Ascendis Pharma

Hellerup, Denmark

Are you passionate about patient safety? Do you have experience within Pharmacovigilance?

If so, now is your chance to join Ascendis Pharma as our new Qualified Person for Pharmacovigilance (QPPV).

We are seeking a passionate EU QPPV to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in the oversight into the functioning of the PV system in all relevant aspects. 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 ~20 colleagues, and report directly to VP, Head Global Patient Safety who is based in Palo Alto, California, USA. You will be based in EU territory (preferably in Hellerup, Denmark).

Your key responsibilities will be:

• To influence the performance of the quality system and the PV activities;
• To promote, maintain and improve compliance with the legal requirements;
• To maintain an overview of medicinal product safety profiles and any emerging safety concerns via signal management process;
• To ensure that the conduct of PV and submission of all PV-related documents are in accordance with the legal requirements and GVP;
• As the head of QPPV office, lead the QPPV team to fulfill specific tasks as required.

Qualifications and Skills:

You hold a relevant academic degree – preferably a relevant academic degree in medicine, pharmacy, or the life sciences and 8+ years of experience within pharmacovigilance and 5+ years of management experience in a Drug Safety organization.

Furthermore, you have:

• Proficiency in English at a professional level, both written and spoken, and you master MS Office;
• Strategic proficiency in crafting approaches to maintain compliance with relevant EMA, FDA, ICH guidelines, initiatives and regulations governing both clinical and post-marketing Safety reporting;
• Knowledge within Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission;
• Solid experience with safety databases (e.g., ARGUS, ARISg etc.) and safety coding dictionaries (e.g., MedDRA, WHODRUG).

Key competencies:

You are a strong team player, analytical, 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.

To succeed in this role, we also expect you to be:

• A highly motivated individual who enjoys being challenged and working in collaborative environments;
• You have strong analytical and communication skills and ability to make high-impact decisions;
• You have solid interpersonal skills and are good at establishing and maintaining working relationships.

Furthermore, the position requires flexibility and the ability to work overlapping hours with colleagues based in Palo Alto, California.