Local Pharmacovigilance Specialist Program

Hello there! I'm Marek, a seasoned lawyer with a deep-rooted interest in drug safety. I'm delighted to welcome you to our top-notch AIDIFY platform where we aim to enrich your understanding of the Pharma industry.

I have devoted years of my career to understanding and navigating the complex world of pharmaceutical regulations, with a strong emphasis on pharmacovigilance. This unique intersection of law and drug safety has offered me a distinct viewpoint, one that I am eager to share with you.

As a proud member of the Polish Society of Pharmacovigilance, I'm continuously updating my knowledge and understanding of the industry's intricacies, keeping myself aligned with the latest trends, regulations, and safety practices.

Having served in various Pharma companies over the years, I've acquired not just theoretical knowledge, but also a wealth of practical insights. I firmly believe in blending theory with practice, which allows me to offer you a balanced and comprehensive learning experience.

Join me on this educational journey, where I aim to equip you with a well-rounded understanding of pharmacovigilance and its legal aspects. Let's shape your future in the Pharma industry together. Your journey with me begins now.

I am Karolina Wawrzyniak and I am a Country Patient Safety Manager at pharmaceutical company. In my daily work I deal with the broadly understood risks associated with administration of a medicinal product and benefit/risk balance. For this reason, I mostly specialize in creating Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Benefit/Risk Analysis and Safety Monitorings. I prepare reports for both the European and Eurasian countries. Furthermore, I specialize in additional risk minimization measures (aRMMs). I take part in many projects related to aRMMs - plan, implement and supervise educational materials and programs (e.g Pregnancy Prevention Programme), coordinate projects related to the switch of the drug legal status, conduct trainings related to risk minimization, cooperate with healthcare professionals, representatives of Competent Authorities, opinion leaders, medical experts and contractors. Additionally, I supervise the processes related to Safety Data Exchange Agreement (SDEA), I cooperate with lawyers and many business partners around the world. Moreover, I am also active in the field of clinical trials – I prepare Development Safety Update Reports (DSURs), supervise the list of clinical and non-clinical trials and I am responsible for collecting and verification of documentation from clinical trials.

I graduated from the Medical University in Łódź in the field of Pharmacy. After 5.5 years of study, I did a six-month internship in community pharmacy, after which I became a Master of Pharmacy. My adventure with the PV department began with an internship in a pharmaceutical company, after which I got the position of a Specialist and then was promoted to the Senior PV Specialist. But already during college I participated in many courses in the field of Pharmacovigilance, Regulatory Affairs and Clinical Trials:

• Introduction to clinical trials
• Introduction to Pharmacovigilance
• Pharmacovigilance – Professional Level of Training
• Principles of Regulatory Affairs for medicinal products, veterinary products with elements of pharmacovigilance management & Documentation for medicinal and veterinary products
• Introduction to collecting and reporting adverse events in clinical research
• Data safety and monitoring boards for clinical trials
• Pharmacovigilance Specialist at Pharmaceutical Company

Medical Projects Manager - skilled in leading, motivating, and coordinating teams and projects. Pharmacist. Mother of a 7-year-old girl.

With over 10 years of experience in the pharmacovigilance sector and expertise in medical information. More than three years of experience as a backup EU QPPV at Poland’s largest pharmaceutical company, Zakłady Farmaceutyczne “POLPHARMA” S.A. Contributed to the development and maintenance of a new set of SOPs and PSMF.

Pioneered a new model of pharmacovigilance activities, overseeing the procurement of pharmacovigilance services. Led the project to establish a new global pharmacovigilance structure for the Polpharma Group.

Nearly four years of experience in people management as the coordinator of periodic reporting and risk minimization teams. Managed 4-5 direct reports.

Responsibilities included:

• Aggregate reports
• Risk management (plans, routine and additional risk minimization activities)
• Pharmacovigilance training for company staff (8,000 employees)
• Safety data exchange agreements
• Pharmacovigilance service agreement
• Extended EudraVigilance Medicinal Product Dictionary reporting
• Post-authorization safety studies
• Safety reporting in clinical trials

Skills:

• Lean management
• Negotiation
• Intellectual curiosity
• Enthusiasm
• Persuasion skills
• Organizational skills
• Proficiency in multitasking with keen attention to detail

After-hours interests:

• Literature
• Rock music
• 1960s fashion and design
• Art history
• Camino de Santiago and the Trans-Siberian Railway

Hello! I am Katarzyna, currently serving as a Junior Pharmacovigilance Manager at Teva Pharmaceuticals, and I am eager to welcome you to the AIDIFY platform.

My journey in the field of Pharmacovigilance has been both diverse and enlightening. After kick-starting my career as a Senior Pharmacovigilance and Regulatory Affairs Specialist, I ascended to more focused roles such as Pharmacovigilance and Eudravigilance Expert, and later as a Manager at Rapofarm. These varied experiences have equipped me with a wealth of knowledge and practical insights in the arena of drug safety.

I hold a Master's degree in Pharmacy from the distinguished Medical University of Warsaw, an academic foundation that has significantly influenced my professional pathway. This solid theoretical groundwork, combined with my industry experience, enables me to provide a comprehensive and applied learning experience.

On this e-learning platform, I am excited to share my insights, tips, and experiences. I am here to help you navigate the intriguing world of Pharmacovigilance and ensure your journey is as enlightening as it is rewarding.

So, come join me, and let's embark on this enriching learning expedition together. The journey to mastering Pharmacovigilance begins now.

Agnieszka is graduated from Faculty of Biology, University of Warsaw, where she also had continued research study earning PhD in Molecular Biology. Mastering the knowledge in life science field and developing transferable skills helped her in clinical research field. Currently, she is a GCP Expert with over 15 years of experience in clinical research as a Contract Research Associate, Trainer and Clinical Quality Manager. Responsible for inspection readiness activities, inspection preparation, facilitation and follow up. Participated in several on-site or remote FDA, EMA and local Health Authority inspections as well as in number of audits when working for CROs or pharmaceutical companies. Actively involved in in-dept root cause analysis of the audit or inspections findings, effective CAPA plans preparation, their follow up and effectiveness check.

Agnieszka is process-oriented, especially in terms of the processes at the site level, as she believes that a good set up of the investigational site for clinical trial is indispensable to its success.

As a member Training Section of the Association for Good Clinical Practice in Poland (GCPpl), she promotes knowledge about clinical trials and ICH GCP in the medical and pharmaceutical industries and likes sharing experience with others.

My name is Maciej Szewczyk and I'm CEO of MS Pharm company – pharmacovigilance provider fully dedicated to deliver Medical Literature Monitoring solutions to pharma industry, with strong focus on publications which are not easily reachable – means published locally and in native languages. I'm involved in this area of pharmacovigilance from 2009 on the different positions, from the project management, through business development including designing of dedicated MLM tools to CEO of company which currently manage over 130 MLM projects and cover over 1000 locally published medical and pharmaceutical journals.

I’m very lazy person in that way, that I’m always trying to automatize or at least maximally simplified all repeatable processes. That’s why we develop dedicated MLM tools which allow us to effectively manage projects we are responsible for.

I like to project and involve in development of software, which will make our life easier and more efficient. I love playing with numbers and statistics, that’s why I was involved in preparation of few analysis regarding literature in pharmacovigilance, e.g.

• “Impact of literature reports on drug safety signals”
• “Identification of information about adverse drug reactions in local medical journals using Medline and Embase versus manual full text review”
• “The drug safety information in domestic medical literature”

I’m also member of Polish Association of Pharmacovigilance and I was involved in creation of Literature Standard of Polish Association of Pharmacovigilance, which was published in Almanach of Polish Regulatory Authority - Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Privately my biggest passion is badminton, skitouring and MTB.

My name is Karolina Smyl and I am a Pharmacist graduated from the Warsaw Medical University in Poland, University of Alcala in Spain as well as postgraduate studies in medical business management. I have 10 years of experience working in the area of Pharmacovigilance. Currently I work as a PV Expert in Medical Department at pharmaceutical company Polpharma, which is a leader of the Polish pharmaceutical market and one of the leading drug manufacturers in the region of Central and Eastern Europe. I am also a member of Polish Society of Pharmacovigilance.

My main responsibilities include preparation of specific pharmacovigilance documents so-called aggregate reports i.e. Periodic Safety Update Reports (PSURs), Addendum to Clinical Overview (ACO), , Development Safety Update Reports (DSURs) from clinical trials, Benefit/Risk Analysis. Risk Management Plans (RMPs) and Additional risk minimization measure (aRMM) are my favorites. I am also responsible for vendors of pharmacovigilance service acquisition.

My daily activities also include updating of Extended EudraVigilance medicinal product dictionary (XEVMPD). Moreover, I supervise the processes related to Safety Data Exchange Agreements.

Since 4 years I have been a PV trainer responsible for initial and annual PV trainings for all employees of the company.

Privately, I am a mother of two wonderful children, with whom I enjoy exploring the world and spending time actively, focusing on a healthy lifestyle.

I encourage you to contact me after the course and for this purpose I leave a link to my LinkedIn.

My professional career includes holding the position of Medical Director in the local affiliates of pharma companies of global reach for several years. On top of other ones, my duties included oversight of local pharmacovigilance processes. As part of it, I was responsible for the setup and the oversight of the local medical literature activities. Being in the role of Drug Safety Officer or the deputy of the DSO for all those years, I had not only the chance to manage this area but also to translate the organizational frames into the daily pharmacovigilance activities in order to be certain the requirements as set out by the GVP are met. As the medical doctor with past academic experience, I am also able to understand the way the medical publications are edited, which adds to the ability to understand the unspoken information in the articles.

For the last 4 years, I have been being involved in supporting the local medical literature monitoring processes at MS Pharm s.r.o., a Czech-based company focused on providing the literature monitoring services. This tenure allows me to further expand my experience by confronting my understanding of the GVP requirements with the stakeholders in the pharmacovigilance area across the pharma industry. Looking at the literature monitoring from a number of different perspectives, it allows me to collate their experiences with these of mine in order to come up with the solutions that fit to the MLM best.