Jana Radiková

Provides coding expertise within Clinical Development for both, project and study teams with responsibility for coding in MedDRA and WHODrug. Oversees the medical coding activities for adverse events, concomitant medications and medical history and the adherence to company and/or product specific coding guidelines. Ensures coding consistency across projects. Supports the selection, implementation and development of a central coding concept covering both clinical study coding as well as coding of spontaneous reports in Pharmacovigilance. Leads the central coding thesaurus management as well as management of thesaurus updates including synonym tables, Standardised MedDRA Queries (SMQs) and company specific groupings. Manages and supervises the outsourcing of medical coding performed by External Service Providers (ESPs), including training, review of deliverables and relationship management.

• Perform clinical trial data coding activities (MedDRA, WHO-Drug, ATC) - Ensure correctness and consistency of coding within the dictionaries - Oversee vendor coding quality - Perform ongoing medical review and data cleaning- generate queries, review responses to queries for appropriateness and resolve any discrepancies - Coordinates with safety department concerning reconciliation of safety data between the clinical and safety databases - Produce coding listings for each dictionary for the review by physicians, pharmacology, safety and epidemiology representatives - Inform and suggest solutions on coding related issues to improve the coding - Review CRFs, data listings and database to ensure that captured data follow the rules outlined by the protocol and data management plan - Develop of company medical conventions Therapeutic area: Cardiology, Neurology

Classify medical (procedures/adverse event/medical history, etc.) and pharmaceutical (drugs) coding terms utilizing MedDRA, WHODrug using Thesaurus Management System (TMS), DsNavigator (DataLabs), ClinPlus, Rave (Medidata), Trialmaster and other. Ensure consistency of coding across projects. Assist with other projects/activities related to medical coding and dictionary maintenance as required. Dictionary maintenance. Train on, and follow, sponsor’s Standard Operating Procedures as applicable. Provide consistent and accurate coding using standardized dictionary terminologies. Manage assigned project timelines and prioritization of tasks. Maintain a clinical understanding of medical terminology, clinical research development, adverse event reporting, and standardized dictionaries. Clarify information through communication with data management and Clinical Operations when terms are inadequate, ambiguous, or unclear for coding purposes. Keep abreast of coding guidelines. Review data for consistency.

Processing the information included in the drug's SmPC (Summary of product characteristics) for the development of the new system for healthcare providers

• Dispensing Rx/OTC medications and consulting activity. - Processing prescriptions for insurance companies. - Performing administration tasks regarding medications supply, stock inventories. - Pharmaceutical formulation.

Drug registration