Pharmacovigilance Compliance Manager
2 weeks ago
We are seeking a skilled Pharmacovigilance Compliance Manager to join our team at Ascendis Pharma A/S, a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.
As a key member of our team, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office, maintaining Ascendis Pharma's global PV system, including its quality system. You will provide oversight and guidance of the QPPV Office operations, contribute to improvements projects and innovation, and be responsible for the maintenance of the PSMF.
This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional, global teams working together to achieve extraordinary results.
You will be joining the QPPV Office team consisting of 2 colleagues, and report directly to Eva Widebæk Rasmussen, Sr. Director & QPPV, who is based in our office in Hellerup.
Your Key Responsibilities Will Be:
- Ensure overall compliance of the PV system and stay 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
- Lead and contribute to the improvement of QPPV and PSMF-related processes and prepare and maintain procedural documents
- Support collaboration with vendors and distributors, including contractual agreements (SDEAs)
- Be part of ensuring inspection readiness
Qualifications and Skills:
You hold a relevant academic degree or similar e.g., Master within a healthcare field, nursing, and have at least 3 years of experience within pharmacovigilance. You have solid knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents.
You have solid experience with MS Office, including MS Excel, Adobe Acrobat, and Sharepoint management.
Key Competencies:
You are a strong team player but also thrive in solving tasks independently, work systematically and with an eye for details, and have a can-do attitude.
You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.
Travel: 10-15 days per year
Estimated Salary: Approximately €60,000 - €80,000 per annum, depending on your level of experience and qualifications
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