69.00€
MAHs ensure that all safety data regarding a medicinal products are available in timely manner to the MAHs so that they may fulfil their legal obligations. A pharmacovigilance agreement (PVA) is a written agreement between the marketing authorisation holder (MAH) and a third party (to which the MAH has shared or activities regarding or impacting pharmacovigilance), which outlines the responsibilities of each party with regards to pharmacovigilance. Such agreements are prepared with the aim of enabling compliance with the legal requirements by each party involved. Would you like to know more about Pharmacovigilance agreement (PVA) and Service provider agreement (SPA)? If so, please join the course!
After course completion, student:
I am Karolina Wawrzyniak and I am Senior Pharmacovigilance Specialist 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 collage I participated in many courses in the field of Pharmacovigilance, Regulatory Affairs and Clinical Trials:
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:
Skills:
After-hours interests:
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