Experience

Emmes Europe - former Neox CRO

• Czechia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, Pharmacovigilance Europe / EU QPPV

  • Jan 2023 - Present

  -Directs and oversees a team of Safety Monitors, Pharmacovigilance Managers and Pharmacovigilance Officers in Europe toimplement CSP activities and reach objectives- Drives selection, onboarding, performance management, personal development plans of new employees.- Supervises maintenance and execution of mandatory training curriculums.- Coordinates safety monitoring activities with Project Medical Monitor.- Reviews safety events.- Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities,health professionals, pharmaceutical and other study partners, as necessary.- Responds to site, Client, pharmaceutical partner requests for information regarding safety in clinical trials.

• EU Senior Pharmacovigilance Manager

  • Aug 2022 - Dec 2022

  Project management: oversee and manage pharmacovigilance projects (both clinical trial safety and post-registration pharmacovigilance) in Europe;Line management: lead a team of pharmacovigilance mangers and officers in EuropeProject start-up activities: communication with clients, contract and budget negotiationSOP development: assist with pharmacovigilance processes set up and support preparation of written standard proceduresMaintain deep knowledge of current local and European pharmacovigilance legislation, providing pharmacovigilance trainingActive participation during audits and inspections, internal quality control activities

• Head Of PV Department

  • Jun 2022 - Aug 2022

• PV Manager

  • May 2022 - May 2022



MSD Slovensko

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmacovigilance Lead for Czech & Slovak Republics

  • Aug 2018 - Apr 2022

  Duties included:• manage pharmacovigilance team in Czech and Slovak Republics• adverse experience case management including HA submissions; aggregatesafety report health authority submissions; health authority submissioncompliance for individual case safety reports and aggregate safety reports• local contractual PV agreements, responsible for the pharmacovigilancereporting language in local country agreements, support for due diligenceactivities• responsible for the audit and inspection activities in the country(ies), includinginternal audits, verification audits, local BP audits and health authorityinspections• dependent on the audit/inspection type, responsibilities include work onreadiness activities; participation in the audit / inspection; development andcompletion of CAPA plans; and assembling of evidence for CAPA closure andfor verification audits• responsible for reviewing local initiatives (e.g., websites, registries, marketinginitiatives), local clinical evaluations, market research, patient support programs (PSPs)• responsible for writing and maintaining the local country PV SOPs, includingalignment with internal policies and procedures and with Global Safetyprocedures for compliance with PV requirements• responsibilities include staff resourcing, training and development andtraining tracking• training of employees• serve as the Local Qualified Person for PV (QPPV) / local responsible PVperson for Czech and Slovak Republics



Johnson & Johnson

• Law Practice
• 1 - 100 Employee

• Local Safety Officer Czech & Slovak Republics

  • May 2007 - Jul 2018

  Duties included:• responsible for drug safety for clinical trials and post-marketing AE´s in CzechRepublic and Slovakia• responsible for SUSAR´s reporting to Investigators and EC´s• responsibility for the coordination of safety reporting requirements asrequired for MAHs• submission of reactions according to Health Authorities• communication with Health Authorities• training of employees• ensure activities are conducted in accordance with current StandardOperating Procedures (SOPs)• write, validate and implement the (local) operating procedures/guidelines• manage and maintain active involvement in day-to-day AE reporting