Pharmacovigilance Office Manager
4 weeks ago
Ascendis Pharma A/S is seeking a highly skilled Pharmacovigilance Office Manager to join our team. As a key member of our organization, you will play a crucial role in ensuring the day-to-day operations of our Pharmacovigilance Office.
About the Role:
- Ensure overall compliance of our Pharmacovigilance system and stay up-to-date with legislation, including driving Pharmacovigilance intelligence activities.
- Coordinate, prepare, and maintain Pharmacovigilance System Master File (PSMF) 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 Pharmacovigilance 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.
Requirements:
- Relevant academic degree or similar, e.g., Master within a healthcare field, nursing.
- At least 3 years of experience within Pharmacovigilance.
- Solid knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents.
- Solid experience with MS Office, including MS Excel, Adobe Acrobat, and Sharepoint management.
- 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.
Key Competencies:
- Strong team player with a can-do attitude.
- Entrepreneurial mindset with the ability to thrive in an informal, open environment.
- Responsible and prioritizes quality in work.
- Good at building relationships even at a distance.
- Good communication skills, both written and verbal.
Travel: 10-15 days per year.
Office: Ascendis Pharma A/S Headquarter, Hellerup.
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