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EU-QPPV / Stufenplanbeauftragter (m/w/d) (DE)
[11707]
Drug Safety / Pharmacovigilance, Stufenplanbeauftragter, Stufenplanbeauftragter / QPPV
Positionstitel: EU-QPPV / Stufenplanbeauftragter (m/w/d) Anstellungsdauer: unbefristet Branche: Pharma Fähigkeiten: Drug Safety / Pharmacovigilance, Stufenplanbeauftragter, Stufenplanbeauftragter / QPPV Idealer Startzeitpunkt: 04.07.2022 Einsatzort: München Aufgaben: ·You will lead the Pharmakovigilanz Team ·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 ·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 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
- You will lead the Pharmakovigilanz Team
- 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
- 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
- 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
Marco Bannier