Pharmacovigilance Operations Manager
1 month ago
Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States, applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives.
As a key member of the Ascendis Pharma team, the QPPV Office Manager will play a crucial role in ensuring the day-to-day operations of the QPPV Office. The successful candidate will support the QPPV and deputy QPPV in maintaining Ascendis Pharma's global PV system, including its quality system, and provide oversight and guidance of the QPPV Office operations, contributing to improvements projects and innovation.
Key responsibilities will include:
- Ensuring overall compliance of the PV system and staying up-to-date with legislation, including driving PV intelligence activities
- PSMF coordination, preparation, and maintenance with key stakeholders in accordance with assigned schedules and current legislation, including local PSMFs
- Oversight and management of deviations and CAPAs
- Leading and contributing to the improvement of QPPV and PSMF-related processes and preparing and maintaining procedural documents
- Supporting collaboration with vendors and distributors, including contractual agreements (SDEAs)
- Ensuring inspection readiness
Requirements include:
- A relevant academic degree or similar, such as a Master's in a healthcare field, nursing, and at least 3 years of experience in pharmacovigilance
- Solid knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents
- Experience with managing the EEA and UK PSMF
- Ability to identify and implement process improvements
- Ability to work on multiple simultaneous tasks with limited supervision
Competencies include:
- Strong team player with an entrepreneurial mindset
- Ability to work systematically and with an eye for details
- Good communication skills, both written and verbal
Travel: 10-15 days per year
Office: Ascendis Pharma Headquarter, Hellerup
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