About the job
Are you enthusiastic about steering Affiliate Pharmacovigilance (PV) activities, enhancing quality processes, and prioritizing patient safety? Do you possess the expertise to integrate local PV requirements into global frameworks while engaging diverse stakeholders and ensuring comprehensive oversight?
If so, seize this opportunity to join Ascendis Pharma as our new Associate Director, Global Affiliate PV Lead.
Ascendis Pharma is a pioneering global biopharmaceutical firm dedicated to improving patients’ lives. With our guiding principles of Patients, Science, and Passion, we leverage our innovative TransCon® technology platform to develop therapies that meet critical unmet medical needs.
Located at our headquarters in Hellerup, Denmark, alongside research facilities in Heidelberg, Germany, and additional offices throughout Europe and the United States, we are actively advancing programs in our Endocrine & Rare Disease and Oncology sectors. We also collaborate with partners to develop TransCon-based products in various therapeutic areas and markets.
We invite a driven individual to join our expanding QPPV Office team. As a pivotal member of the Ascendis Pharma Global Patient Safety team, you will contribute significantly to overseeing safety initiatives and the continuous enhancement of our PV system. This role offers an exciting chance to work in a dynamic environment, partnering with cross-functional, global teams striving for exceptional outcomes.
You will join the Global Patient Safety (GPS) team, consisting of approximately 20 colleagues, and report directly to the Head of QPPV Office & QPPV, Annemette Boye, who is based in Hellerup, Denmark. Your workspace will be in Hellerup, Denmark, alongside the QPPV Office team.
Your primary responsibilities will include:
- Leading the global PV oversight for Ascendis Affiliates, ensuring full compliance with local regulations and integration with our global PV framework. This encompasses:
- Defining and maintaining global and local PV procedural strategies, including impact assessments and implementation of regulatory changes.
- Establishing and supervising local literature monitoring, ensuring alignment and quality across global and local teams.
- Engaging with Affiliates and GPS to ensure transparent communication and mutual compliance.
- Driving PV preparedness for product launches across all Affiliates.
- Leading Affiliate PV audits and inspection activities in close coordination with GPS, cross-functional teams, and QA.
- Overseeing Affiliate-related PV deviations and quality management.
- Collaborating with the PV Alliance Management Lead to ensure consistent processes for Affiliates and other markets.
