EU QPPV, Head of QPPV office

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).

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

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

Travel: 15-20 days per year.

Office: Tuborg Havn in Hellerup Denmark

Apply now.

Applications will be evaluated when received so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

For more details about the position or the company please contact Mandeep Singh MD. V.P. Head of Global Patient Safety mail:

You can learn more about Ascendis by visiting our website

Applications submitted via email or other channels will not be reviewed.

A note torecruiters:

Wedo notallowexternalsearchparty ofcandidateswithoutwrittenpermission from the Ascendis PharmaHR team(specificallyfrom: TalentAcquisitionPartner or Human ResourcesDirector) is .

Required Experience:

Director