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Chief Pharmacovigilance Operations Specialist
2 weeks ago
Established in Denmark, Germany, and the United States, Ascendis Pharma is a fast-growing biopharmaceutical company driven by its core values of patients, science, and passion. Our mission is to develop new and potentially best-in-class therapies to address unmet medical needs.
We utilize our TransCon technology to build a leading, fully integrated biopharmaceutical company. Our pipeline consists of prodrug therapies designed to be best-in-class treatments. As we continue to grow, we seek talented individuals who share our vision.
The QPPV Office Manager will play a pivotal role in ensuring the day-to-day operations of the Quality, Pharmacovigilance, and PSMF systems. Key responsibilities include:
- Maintaining compliance with PV legislation and staying up-to-date with regulatory developments
- Coordination, preparation, and maintenance of PS KernSafe & ICH GCP adherence including collaboration with stakeholders
- Oversight and management of deviations and CAPAs, as well as process improvements for QPPV and PSMF-related processes
- Supporting vendor and distributor collaborations, including SDEA agreements
To succeed in this role, you must possess relevant academic qualifications and at least 3 years of experience in pharmacovigilance, including knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable guidance documents.
You should have solid experience with MS Office, including Excel, Acrobat, and SharePoint management. Additionally, you should be able to identify and implement process improvements, work on multiple tasks simultaneously, and thrive in an informal environment where innovation and change are key.
Key competencies include being a strong team player, working systematically, and having a can-do attitude. You should also possess an entrepreneurial mindset and good communication skills, both written and verbal.
This role involves occasional travel (10-15 days per year) and reporting directly to Eva Widebæk Rasmussen, Sr. Director & QPPV. We welcome applications from motivated professionals looking to make a meaningful contribution to our growing team.
