Pharmacovigilance and Compliance Manager
4 weeks ago
Are you passionate about pharmacovigilance and compliance management? Do you have experience in a drug safety environment with pharmacovigilance operational responsibilities? If so, now is your chance to join Ascendis Pharma as our new PSMF & QPPV Office Manager.
Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
We are seeking a passionate QPPV Office Manager to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office. You will support the QPPV and deputy QPPV in maintaining Ascendis Pharma's global PV system including its quality system, providing oversight and guidance of the QPPV Office operations and contribute to improvements projects and innovation. Moreover, you will be responsible for the maintenance of the PSMF and provide PSMF related subject matter expertise.
Your key responsibilities will be:
- Ensure overall compliance of the PV system and stay up-to-date with legislation including drive PV intelligence activities
- PSMF coordination, preparation and maintenance with key stakeholders in accordance with assigned schedule and current legislation including local PSMFs
- Oversight and management of deviations and CAPAs
- Lead and contribute to the improvements 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 health care 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.
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. Office: Ascendis Pharma Headquarter, Hellerup
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