Vigilance Operations, EU QPPV
In her EU QPPV role, Alina is responsible for the management and maintenance of different pharmacovigilance systems for all types of products (drugs, biologics, etc.), ensuring that all the proper means are in place to comply with applicable regulations. This includes preparation/review of Pharmacovigilance System Master Files (PSMF), Standard Operating Procedures (SOPs), Pharmacovigilance Project-Specific Procedure (PV-PSP), Safety Data Exchange Agreements (SDEA), Periodic Safety Reports (PSUR/PBRER) review; signal management activities, safety database maintenance, ensuring compliance for Individual Case Safety Reports (ICSRs) processing and transmission.
As part of her EU QPPV role, Alina is also responsible for reviewing and approving Risk Management Plans (RMP). Alina is certified for Eudravigilance and can act as Eudravigilance responsible Person (EVRP) for Sponsors.
She previously worked as EU QPPV and Pharmacovigilance Manager at Alvogen Group of Companies for 4 years, where she established and maintained the Pharmacovigilance System of the Group, covering more than 150 active substances submitted or approved in over 30 countries worldwide. In her EUQPPV role she passed several audits, ensuring timely resolution of all findings.
Prior to that, Alina was part of the corporate pharmacovigilance team of Actavis Group, where she acted as Pharmacovigilance Officer and Safety Evaluation Group Team Leader, being mainly responsible for PSUR, RMP preparation and Signal Detection activities, covering a broad portfolio, approved in more than 40 countries worldwide.
Alina is a graduated Medical Doctor, with a Bachelor Degree at the Carol Davila Medicines and Pharmacy University in Bucharest, Romania. During her years in pharmacovigilance activities she has strengthen her knowledge by attending multiple international conferences and trainings. Alina is based in London.