Katarzyna Krzemieńska

Dec 2010 – Today
Qualified Person for Pharmacovigilance (QPPV).Pharmacovigilance of medicinal products. Collection and analysis of data regarding adverse drug reactions. Cooperation in the field of adverse drug reaction, adverse events with division of clinical trials, division of quality, division of medicinal products registration in the company. Creation of Periodic Safety Update Reports. Creation of and updates to Standard Operating Procedures concerning pharmacovigilance compliant with Polish and European legislation. Verification of document translation in the area of pharmacovigilance. Creation of pharmacovigilance agreements in English with foreign contractors. Correspondence regarding pharmacovigilance in English with foreign contractors. Review of English scientific literature for pharmacovigilance aspects. Monitoring of safety of use medical devices and cosmetics manufactured by company. Participating in updating of Summary of Product Characteristic(SmPC) and Package Leaflet (PL) in the field of pharmacovigilance. Updating of the abovementioned documents in compliance with Polish and European legislation. Verification of
translations and help with translation into English of SmPC and PL documents. Conducting internal trainings in pharmacovigilance. Providing information on pharmacovigilance to the customers and health professionals.

Pharmacy “W Rynku” in Olkusz; pharmacist.
Responsibilities: handling deliveries of drugs; registering invoices; payments; data base updates; store management (avoiding drug expiration, drug layout optimization in order to accelerate customer service); medicine compounding; customer service, including English
speaking customers;

Pharmacy “Długa 48” in Krakow; pharmacist, co-owner.
Responsibilities:
setting up the pharmacy from scratch, including: the supervision of the retail storefront finishing according to pharmaceutical legislation; managing the certification of the materials used in the retail storefront finishing; acquisition of the required equipment; providing Pharmaceutical Inspectorate, Sanitary and Epidemiological Station, as well as all other pharmacy and sole proprietorship related organizations with the required documentation; negotiating agreements with pharmaceutical warehouses; store management; income and customer service optimization; servicing English speaking customers; recruitment.