PV/QA & Specialist

Purpose

We are looking for experienced pharmacovigilance and quality specialist to join our team in Bratislava who will be also supporting our Regulatory department in Czech Republic. The ideal candidate will have a strong background in pharmaceutical regulations, with proven expertise in pharmacovigilance procedures. Excellent communication skills and the ability to effectively collaborate with cross-functional teams are essential for success in this role.

Main Responsibilities

• Management of ADRs – reporting, archiving.
• Management of PSUR, RMP, EdM and DHCP (and other RMM) in collaboration with SUKL.
• Distributions of information on risk minimization measures to relevant departments.
• Monitoring of local literature and webpages for safety issues for both countries.
• Planning and providing PV/quality and products complaints training for Chiesi 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 Chiesi corporate policies for both countries.
• Administrative support for Regulatory department in Czech Republic.

Experience Required

• At least 2 - 3 years’ experience in a similar position.
• Knowledge of Gx Practices and MS Office.
• Excellent verbal and written communication skills.
• Strong attention to detail.
• Excellent ability to work with others both cross-functionally and internationally to achieve goals.

Education

• University degree

Languages

Slovak: native speaker

English: advanced level

Soft Skills