Associate Director, QPPV office, Global Affiliate PV Lead

Gentofte Kommune - Denmark

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

Description

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.

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 Endocrine & 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 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 Boyewho 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 twoway communication and mutual compliance
Drive PV readiness for product launches across all Affiliates
Lead Affiliate PV audits and inspection activities coordinating closely with GPS crossfunctional teams and QA
Oversee Affiliaterelated 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 pharmacovigilanceand 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

Travel: 10 - 15days 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

DescriptionAre 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 oversightIf so now is your chance to join...