Elena Zelenskaia

Hello! My name is Elena Zelenskaia and I have over 7 years of experience in Pharmacovigilance in various roles including managing positions. Proved myself as a strong team player with great communication, organization, and time management skills. Specialised in the safety of biologics, and biopharmaceutical products, including OTC, generics, cosmetics, and food supplements. Have complete knowledge of overall Pharmacovigilance Practices for both EU and EAEU/CIS regions. Experienced in PV systems establishment and maintenance including PSMF preparation and SOPs development.

In the role of PV manager:

Organised a pharmacovigilance quality management system for the EAEU region, in relation to the updates of the requirements of the EAEU GVP and in conjunction with global processes.
ꟷ Organised proper safety monitoring of the Company’s medicinal products authorised in the EAEU Member States with full compliance with established KPIs.
ꟷ Developed and implemented a system of local literature monitoring in the EAEU region.
ꟷ Established successful Cross-functional collaboration with Quality Assurance, Regulatory Affairs, Business Development and Clinical Trials Departments both at global and local levels.
ꟷ Ensured timely updates of the EAEU PSMF in connection with the transition to the new requirements of the EAEU GVP.
ꟷ Contributed to the optimization of the performance of routine PV activities by applying the best practices and new approaches in the industry.
ꟷ Acted as a single PV contact point for the competent authorities in the Member States on a 24-hour basis.
ꟷ Ensured continuous inspection and audit readiness.
ꟷ Ensured timely preparation and updates of RMPs both for registration and routine PV purposes without objections from Competent Authorities

2022 Course for Qualified Person Responsible for Pharmacovigilance (QPPV)
Sechenov University, Moscow
2011 Internship at Ryazan State Medical University on Economic and Pharmacy management.
Pharmacy, Pharmacist
2010 Ryazan State Medical University named after academic I. P. Pavlov
Pharmacy, Pharmacist