Eva Muenster

I am eager to introduce myself as a goal-oriented individual, who believes in the motto Never give up—where others stop, I am just getting started.

Currently I am employed as Pharmacovigilance Assessor. I am responsible for the review of the Pharmacovigilance (PV)Part of the registration dossier for drug approvals, type I and II variations and renewal documentation such as RMPs (Risk Management Plans), PSURs (Periodic Safety Update Reports). Furthermore, I am responsible for assessing Post authorization Safety Studies (PASS) and clinical parts of the registration dossier documents.

Previously I worked as EU-Qualified Person for Pharmacovigilance (PV) and Medical Information for a Vienna-based company with affiliates mainly in the Eastern European countries. In the past I was also employed in an international pharmaceutical company where I was Local Person responsible for Pharmacovigilance (PV) over a long period of time. In addition, I developed expertise as Quality Assurance and Information Officer according to the Austrian Medicinal Drug Act. I was also Deputy of the Head Medical and Study Manager. Furthermore, my additional qualifications were developing PV- and Quality contracts with business partners and local PV service providers in other countries. My key tasks comprised also PSUR writing/submission, RMPs, Adverse Event Management, Quality complaint handling, supporting Audit and Inspections, conducting PV Trainings, developing and maintenance of Standard Operating Procedure (SOPs) - all in close collaboration with the Quality, Regulatory Affairs and Marketing department. 

During my past work experiences, I was able to demonstrate my talent very well. My empathy skills and ability to collaborate effectively with other people demonstrates both my personality and my work methodology. 

I would be highly appreciative to be able to persuade you with my motivation personally! 

Pharmacovigilance Assessor (since 2022): Responsible for reviewing the PV section of registration dossiers for drug approvals, including Type I and II variations, renewal documentation, Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Post-Authorization Safety Studies (PASS), and clinical components. 

Previously, I served as an EU-Qualified Person for Pharmacovigilance (PV) and Medical Information for a Vienna-based company with affiliates in Eastern Europe. I have also been the Local PV Officer at an international pharmaceutical company and gained experience as a Quality Assurance and Information Officer under the Austrian Medicinal Drug Act. Additionally, I have developed PV and Quality contracts, written and submitted PSURs, managed adverse events and quality complaints, supported audits and inspections, conducted PV training, and developed and maintained Standard Operating Procedures (SOPs).

Exam for the pharmacist profession (January 2002). 

Clinical Pharmacy/Medication Management- Postgraduate Certificate Course - University of Vienna: 04/2021-07/2021

CAE Cambridge Level C1: 03/2021