PV/QA Specialist

Pharmacovigilance and Quality

• Management of ADRs – reporting, archiving.
• Management of PSUR, RMP, EdM and DHCP (and other RMM) in collaboration with ŠUKL.
• Distributions of information on risk minimization measures to relevant departments.
• Monitoring of local literature and webpages for safety issues.
• Planning and providing PV/quality and products complaints training for SK employees.
• Monitoring of local processes and changes in collaboration with SUKL, regular monitoring of SUKL and MoH webpage.
• Contribution on processing, reporting changes in the safety and quality issues of products.
• 24 hours availability for safety issue communication
• Evaluation of PV aspect of local NIS, MR and IIT including the PV training of external providers (if applicable).
• Responsibility for regular updating company´s databases/systems
• Process lifecycle of document management including creating, updating, monitoring, archiving standard operation procedures (SOPs), working instructions (WIs) in documentation system for both countries.
•  Participation in audit and inspection activities for both countries.  Support with day-to-day management of local Pharmacovigilance system and ensuring local compliance with PV regulations and company corporate policies for both countries.
•  Administrative support for Regulatory department in Czech Republic.
  

• práca v medzinárodnej originálnej farmaceutickej spoločnosti
• príjemné a priateľské pracovné prostredie
  
• práca z domu- čiastočná
• samostatnosť a osobný rozvoj
• aktívne školenia a vzdelávanie
• motivačné finančné benefity