KRISTINA FUTRIKANICOVA

• PHARMACOVIGILANCE, MEDICAL INFORMATION AND PRODUCT QUALITY COMPLAINT OPERATIONS SPECIALIST
• Database experience: Oracle Argus Safety, Veeva, MedDRA, APEX, Jasper, QC Selector
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements for different global markets.
• Perform Pharmacovigilance activities including but not limited to collecting and tracking incoming Adverse Events (AE)/ endpoint information, controlling validation of incoming ICSR.
• Processing different types of cases based on the source identification (Spontaneous, Non-Interventional Study, PSP, MRS, etc.); experience as well as in literature surveillance. Reconciliation of cases against regulatory listings, Safety Data Exchange Agreement (SDEA).
• Completed client notifications per case management and participated in regular client meetings.
• Develop training materials and conduct training presentations
• Detection, validation and evaluation of medical information provided from different sources.
• Creating Adverse Event and Product Quality Complaint (PQCs) reports requiring concise data entry covering everything from patient symptoms, admission and results – this includes medical terminology, writing narratives, generating case queries.
• Mailbox management, managing workload of other clusters, working as workflow lead.
• Identify quality problems (CAPA), raising deviation, controlling Late Logs and being part of the team during audit procedures.
• Performing support activities such as Quality Check and reviewing of cases, documents, emails.

Perform case processing of adverse events, conduct follow up, determining seriousness and expectedness at the event and case level, write accurate and complete narratives in accordance with internal guidelines, SOPs and EMA and FDA safety regulations.

Pharmacovigilance case processing:

• Case follow up activities
• MedWatch/CIOMS/E2B Preparation
• Oracle Argus Safety environment
• Eudravigilance database

Develop training materials, conduct training presentations and on-the-job training for call center, medical information and pharmacovigilance staff.

Review and process information from Client specific reports, such as, but not limited to BO (business operations) Report and RPA (Robotic Process automatization) follow-up reports (NINA).

Translation of relevant information from source documentation with quality check of already received translations.

• Performs clinical laboratory tests, procedures and analysis to provide data for COVID-19 Clinical Diagnosis.
• Prepares specimens for analysis and organizes tests to be performed.
• Reviews test results, maintains legible work records, and enters findings into the laboratory information systems.
• Verifies proper instrument function by checking and calibrating lab instruments and documents data.
• Records on instrument log any repairs, replacement and maintenance on laboratory instruments such as Janus G3 Automated Workstation and Chemagic 360.