Monika Zych | Director, Pharmacovigilance
Baxter

Graduated from Medical University in Warsaw as Master of Pharmacy and gained PhD degree in the field of pharmaceutical botany. Afterwards, started her career in consulting company dealing with medical writing. For 16 years has been deeply involved in all areas of Pharmacovigilance. In the consulting company developed full and partial Pharmacovigilance system used by many clients and managed team responsible for wide range of Pharmacovigilance activities from AE collection and processing, PSUR, RMP preparation, signal management to quality systems in Pharmacovigilance. Nominated as QPPV for several companies. After gaining wide experience in consulting company, she joined in 2015 global company Baxter Healthcare as head of Pharmacovigilance for ECEMEA region (Central Europe, Middle East, Russia and CIS) to set up effective and efficient Pharmacovigilance system by building flexible system comprising internal team and external vendors. Leading several audits and inspection gained wide experience in the auditing area. Currently, as Pharmacovigilance Director responsible for directing internal and external teams in Pharmacovigilance operations, ensuring smooth cooperation between internal and external resources and highest compliance in the managed ECEMEA region.