NextPV Services
Jan Kolouch is currently serving as the EU QPPV & Strategic PV Advisor at NextPV Services, overseeing the establishment and maintenance of PV systems. Previously, Jan has held various leadership roles in pharmacovigilance at companies like DIA, PVpharm, PrimeVigilance Ltd., and PharmInvent. With a Doctor of Pharmacy degree in Pharmacology and Toxicology, Jan has extensive experience in managing pharmacovigilance activities, providing expert advice, and overseeing processes within the pharmaceutical industry.
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NextPV Services
Everything we do, we do with the aim to elevate the science of pharmacovigilance and make the patient and drug safety a seamless endeavour. Contact us via info@nextpvservices.com. We offer a wide range of expert services with focus on the following: QPPV services -EU QPPV and Deputy EU QPPV services, Global QPPV support/advice -Local QPPV/Local contact person for pharmacovigilance services/management PV systems -Full PV system outsourcing, including all required PV activities -Review of current system with proposals for improvements -PSMF development and maintenance -Development of company’s quality management system, including Standard Operating Procedures (SOPs), Working Instructions (WI), Policies etc. Artificial intelligence -Advice and support on Artificial Intelligence powered tools for your organisation. Hands-on experience with variety of currently available tools (areas of ICSR/case processing, signal management, literature screening) EudraVigilance (EV) and eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) -EV registration, setup and maintenance -Advice on ISO IDMP implementation Signal and Benefit/Risk Management -Setup, review and optimization of signal management for your organisation -EVDAS advice, support and implementation for your organisation -Additional Risk Minimisation measures advice for your products Audits -PV system audits, gap analysis, support during audits/inspections -Inspection/audit readiness support and training PV Trainings -GVP trainings (complete GVP modules training available) -Any other PV activities focused trainings (e.g., Signal Management, ICSR Managemenet, EU QPPV) Safety database -Safety database setup/maintenance, including validation ICSR/case management -End to end ICSR management, including expedited reporting to health authorities -Expert advice on the whole process and its optimization Medical writing -Preparation of PSURs/PBRERs, RMPs, DSURs, ACO