Associate Director, deputy QPPV
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Job Location:
Gentofte Kommune - Denmark
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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.
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 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 Boyewho 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 24hour 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
Travel: 10-15 days per year.
Office: Tuborg Havn in Hellerup Denmark
Apply now.
We evaluate applications when received so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.
To ensure your application is reviewed please submit it through the specified platform - applications sent by email or other channels will not be evaluated.
For more details about the position or the company please contact Annemette Boye
You can learn more about Ascendis by visiting our website
Applications must be submitted in English and will be treated confidentially.
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Required Experience:
Director
Key Skills
- Fiscal Management
- Public Health
- Fundraising
- Management Experience
- Conflict Management
- Nonprofit Management
- Strategic Planning
- Administrative Experience
- Budgeting
- Leadership Experience
- Public Speaking
- Supervising Experience
About Company
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a ... View more
