PVG MANAGER / MUB
2012-10-17
Our client, biotechnology company developing new therapies is looking for Pharmacovigilance Manager.
Qualification/background
Advanced degree in healthcare related field (MD, PharmDr, Life Science), experience with product safety/PV in biopharmaceutical industry (including CA, CRO, BioPharma) in clinical development
Responsibility/key activities
PV system, product safety management (including the collection, processing, reporting of AEs), compliance with external regulation of PV/product safety in Europe, USA, readiness for PV audits and inspections, involvement with PV audits and inspections, liaising with external parties , PV risk assessment and risk minimisation, PV/product safety training and education, PV/product safety SOPs, PV budget, review and submission of aggregate reports (safety data)
Skills/knowledge/competencies
Working knowledge of Czech and international (EU,US) product safety/PV regulatory environment, fluent English, ability and willingness to learn, willingness to travel, communication skills
Region: Czech Republic, Europe, USA
In case of interest please send your CV to Marcela Bukačová at bukacova@hays.cz
