As the workstream leader for establishing Sandoz’s standalone Pharmacovigilance (PV) system, I played a crucial role in transitioning the PV operations from Novartis to an independent setup for Sandoz. My mission was clear: to create a globally compliant PV system that would support Sandoz as it embarked on its journey as a standalone entity. This involved a comprehensive strategy, from hiring the right talent in various regions to integrating local PV requirements with the company’s… Show more As the workstream leader for establishing Sandoz’s standalone Pharmacovigilance (PV) system, I played a crucial role in transitioning the PV operations from Novartis to an independent setup for Sandoz. My mission was clear: to create a globally compliant PV system that would support Sandoz as it embarked on its journey as a standalone entity. This involved a comprehensive strategy, from hiring the right talent in various regions to integrating local PV requirements with the company’s overarching business goals. Upon the project’s successful completion, I was entrusted with the role of Patient Safety Head for countries and regions, overseeing North America, Europe, APMA, Japan, and LATAM. This new challenge required me to establish and select regional leads, ensuring that our PV system was not only maintained but also continually improved. I spearheaded efforts to build a cohesive network that bridged local and global operations, ensuring compliance and effective communication across more than 140 countries. My leadership extended to over 60 individuals in various positions, driving strategic, operational, and organizational management. I worked closely with global process owners and regulatory bodies to ensure compliance and reduce complexity, always keeping patient safety at the forefront. Through my efforts, I influenced both the internal and external PV environments, advocating for regulations that protect patient health while ensuring that Sandoz’s products remained accessible worldwide. In essence, my journey from establishing a standalone PV system to leading global patient safety efforts has been driven by a commitment to excellence, compliance, and patient-centric strategies, ensuring that Sandoz operates with a robust and compliant PV framework globally Show less

Responsible for the pharmacovigilance/vigilance system in the Czech Republic, Lithuania, Latvia and Estonia. My team is the multinational team composed form people form the Czech Republic, Slovakia, Romania, Latvia, Lithuania and Estonia. I´m proud on this multinational diversity, because this makes us stronger!

Serve as the company manager for the GDD functional heads in the Czech Republic, on behalf of the Country PresidentResponsible for building and maintaining working relationships across GDD functions and with the key stakeholders at a country levelRepresent GDD at Country Executive Committee

Responsible for management the local Novartis Patient Safety team which covers pharmacovigilance of Novartis’s, Sandoz´s and Alcon´s medicinal products, cosmetics and food supplements and vigilance including technical complaints of Alcon´s surgical and vision care medical devices.Responsible for management and implementation of the local risk management measures.Serves as local contact person (Novartis, Sandoz and Alcon) for pharmacovigilance and vigilance towards the State Institute… Show more Responsible for management the local Novartis Patient Safety team which covers pharmacovigilance of Novartis’s, Sandoz´s and Alcon´s medicinal products, cosmetics and food supplements and vigilance including technical complaints of Alcon´s surgical and vision care medical devices.Responsible for management and implementation of the local risk management measures.Serves as local contact person (Novartis, Sandoz and Alcon) for pharmacovigilance and vigilance towards the State Institute for Drug Control.Responsible for implementation of global projects into the local environment in line with the local legislation. Show less

I oversee, manage and support management of DS&E operational processes at Country Pharma Organization (CPO) in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/ guidelines for pharmaco-devicevigilance of Novartis marketed and investigational products (drug and devices).I act as the National Qualified Person for Pharmacovigilance in the Czech republic and as the single point of contact with the Czech Health Authority on a… Show more I oversee, manage and support management of DS&E operational processes at Country Pharma Organization (CPO) in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/ guidelines for pharmaco-devicevigilance of Novartis marketed and investigational products (drug and devices).I act as the National Qualified Person for Pharmacovigilance in the Czech republic and as the single point of contact with the Czech Health Authority on a 24-hour basis concerning Pharmacovigilance. Show less

• Focus on ensuring patient safety during clinical trials and registries.• Conduct adverse event reviews and handle processes in accordance with the requirements and ethics demanded of trial sponsors.• Participate in Clinical Events Committees to ensure literature and congress data are accurate and reliable.• Co-manage intercontinental MedDRA implementation into clinical trials linked to medical devices

Worked as Senior pharmacovigilance manager• Led and supervised the team of four people including external partners• Built this sub-department according to pharmacovigilance legislation (valid from 2011)• Responsibilities also included providing and approving documents for new registrations, signal detection on whole company generic portfolio• Planned of capacities according to daily workload• Negotiated with other departments, countries and competent… Show more Worked as Senior pharmacovigilance manager• Led and supervised the team of four people including external partners• Built this sub-department according to pharmacovigilance legislation (valid from 2011)• Responsibilities also included providing and approving documents for new registrations, signal detection on whole company generic portfolio• Planned of capacities according to daily workload• Negotiated with other departments, countries and competent authorities• Made presentations for internal and external use/partnersAbsolved personal coaching course for managers focused on managers skills and leading of a team (September 2013 – June 2014) Show less

Additional function to Head of signal detection and risk management sub-dpt.• Ensured duties of QPPV during QPPV´s absence• Responsibilities included controlling the whole pharmacovigilance system during QPPV´s absence• Supervised pharmacovigilance department during director´s absence• Involved in QPPV office responsible for enhancing the pharmacovigilance system between company´s entities and continuous supervision of risk-benefit-efficacy of the company’s portfolio

• Responsibilities included management of individual case safety reports (ICSR), writing risk management plans, periodic safety reports, MedDRA database administration, education and training agenda• Co-Led migration project of legacy pharmacovigilance databases into global safety database

• Responsibilities included supporting of pharmacovigilance managers• Participated in daily routine activities (preparation of documents, monitoring of risk-benefit balance)

Received practice in Regulatory Affairs, Quality and Pharmacovigilance, Research and Development, Clinical department, Human Resources and Marketing

Dispensing of drugs, communication with patietns and physicians