Natallia Bahachova (Bogacheva)

- Led and conducted signal detection and evaluation activities using clinical trial and post-marketing data - Authored and reviewed Signal Assessment Reports (SARs) supporting global safety evaluation - Contributed to preparation of aggregate reports (PSUR, DSUR, PADER), including data analysis and section authoring - Prepared and supported responses to FDA and EMA queries - Presented safety analyses at Safety Review Committee (SRC) meetings - Collaborated cross-functionally with Regulatory, Clinical, and Medical teams With my medical background, I apply clinical insight to safety data analysis and continue to build expertise in medically informed case assessment and narrative development.

- Led end-to-end pharmacovigilance system oversight across CIS/EAEU region, ensuring compliance with local regulations aligned with EU GVP requirements. - Managed and mentored a team of PV professionals (3 managers), overseeing execution of pharmacovigilance activities and ensuring compliance with regulatory timelines - Served as primary pharmacovigilance contact for Health Authorities, leading regulatory communications and responses - Led inspection readiness activities and participated in regulatory inspections (including 2023 Kazakhstan Health Authority), with no critical findings; developed and implemented CAPA - Oversaw planning and execution of aggregate reports (PSURs, DSURs), and RMPs, ensuring completeness, quality, and timely submissions - Implemented additional Risk Minimization Measures (RMMs) in line with regulatory requirements - Reviewed safety sections of clinical study documents (protocols, Investigator’s Brochures, ICFs) - Managed local PV agreements, SOPs, and vendor oversight activities

• Promoted to a leadership role within 4 months, recognizing strong performance and ownership of pharmacovigilance activities • Served as Local QPPV, responsible for pharmacovigilance system management and regulatory compliance for post-marketing products • Managed and maintained the pharmacovigilance system, including case processing, safety reporting, and preparation of aggregate reports (PSURs), ensuring data quality and timely submissions • Developed and implemented SOPs and PV processes in line with local regulations aligned with EU requirements; supported audits with no critical or major findings and implemented CAPA plans

• Progressed from PV Specialist to Lead Specialist, taking on increasing responsibility for pharmacovigilance activities • Established and maintained pharmacovigilance system from the ground up, including case processing, safety monitoring, and regulatory reporting • Ensured compliance with local pharmacovigilance regulations, including timely submission of PSURs and implementation of risk minimization measures • Supported audits and inspections with no critical findings

• Provided ophthalmology and vision care services, including patient consultations and visual assessments • Applied clinical knowledge in a commercial healthcare setting, supporting patient care and treatment recommendations

• Provided medical information on pharmaceutical products and supported healthcare professionals • Developed understanding of drug properties and healthcare systems

• Provided clinical care in ophthalmology, including diagnosis and management of eye diseases (glaucoma, cataracts, inflammatory conditions) • Applied clinical judgment in patient assessment and treatment decision-making • Developed strong foundation in medical data interpretation and patient safety