EU-QPPV / Stufenplanbeauftragter (m/w/d)
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München |
Permanent
Positionstitel: EU-QPPV / Stufenplanbeauftragter (m/w/d)
Anstellungsdauer: unbefristet
Branche: PharmaFähigkeiten: Pharma, Drug Safety / Pharmacovigilance, Stufenplanbeauftragter / QPPV
Idealer Startzeitpunkt: ab sofort
Einsatzort: München
Aufgaben:
- You will lead the team and manage the PV and RA department
- The Qualified Person for Pharmacovigilance (EU-QPPV) ensures a proper handling of medical drug risks according to regulatory requirements.
- Acting as a single pharmacovigilance contact point for the CAs in MSs and the EMA on a 24-hour basis and also as a contact point for pharmacovigilance inspections
- Departmental budget responsibility and reporting
- Establishment and maintenance of the pharmacovigilance system to ensure collection, evaluation and processing of all suspected adverse reactions.
- Writing of documents and documentation to describe the pharmacovig ilance system such as pharmacovigilance system master file (PSMF)
- Having overview over the whole Pharmacovigilance system of MAH with all its elements (such as Quality control and - assurance , SOPs, Database operations, contractural arrangements, compliance, audits, training of personel in relation to pharmacovigilance)
- Continuous scientific evaluation of benefit-risk balance and safety profile of drug
- Preparation and expedited reporting of PSURs for responsible competent authorities respecting the relevant deadlines
- Regulatory strategy and planning of marketing authorisation projects
Qualifikationen:
- University dgree of Medicines or Natural Sciences
- Several years of professional expertise in the area of Pharmacovigilance
- Excellent knowledge of relevant phamacovigilance legislation, EU guidelines and relevant processes
- Very good language skills in English, in addition very good language skills in German (spoken and written)
- Excellent organisation skills and strong sense of responsibility
- Working in a structured, precise and deadline-focused way
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Marco Bannier
m.bannier@aristo-group.com
+49 89 599 1827 200
11574
Pharma
ab sofort
n. A.
Permanent
