QA / QP PV Officer

We are looking for an experienced person to deliver the specific duties of the EU Qualified Person for Pharmacovigilance (EU QPPV) and to maintain oversight of the EU element of the established hameln Pharmacovigilance system and to maintain QA Management system.
The main responsibilities:
• Pharmacovigilance System Master File (PSMF):
Maintenance of the Pharmacovigilance System and PSMF.
• Quality Management Systems:
Maintenance of the PV Quality Management System and associated quality‐ related activities including Audit, Compliance Monitoring including implementation of CAPAs and Quality Improvement. Participation in audits and inspections.
• EudraVigilance:
Management of case data, signal detection activities on the EudraVigilance dataset, maintenance of product information and administration of company accounts
• Product labelling:
Updates to product labelling (SmPC, PIL, packaging) and oversight of associated regulatory activities.
• Communication: With the EMA and other EU health authorities.

• Extensive training
• Self-reliant and responsible work
• Participation in a dedicated team
• Exciting tasks
• Growing company
• Flexible working hours

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Zaslaním Vášho životopisu zároveň dávate súhlas so spracovaním Vašich osobných údajov uvedených v životopise za účelom výberu uchádzačov v zmysle Zákona č. 122/2013 Z.z. o ochrane osobných údajov.