Dra Manager
CurrentTotal responsibility for the regulatory and pharmacovigilance process in Poland.Reporting directly to the Headquarter.Development, authorization and maintenance of the Bionorica products on the Polish market.• Interaction with Local Health Authorities (HA) and Headquarter.• Regulatory Submissions in line with local HA expectations, SOPs and business objectives.Marketing Authorisation (MA) applications (National, MRP, DCP).Variations and other MA maintenance applications. Dossier updates of Bionorica products. Ensuring the compliant labeling in the country (SmPC, PIL, packaging) in accordance with CCDS and global design projects.• Pharmacovigilance activities:Translating and processing of AEs from all sources. Searching local literature sources for identification of ICSRs and other relevant PV information.Regular Trainings for the field and office staff on pharmacovigilance.Regular Pharmocovigilance Update Report compiling (on quarterly basis).• Support for medical and sales department:Approval of promotional materials.Medical and product trainings for sales and marketing department.Advisory Board speaker.Product presentations for opinion leaders and company clients.
