Pharmacovigilance Compliance Manager
3 days ago
Are you passionate about pharmacovigilance and compliance management?
We are seeking a highly skilled Pharmacovigilance Compliance Manager to join our team at Ascendis Pharma. As a key member of the QPPV Office, 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.
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
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.
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