Mireia Vallès Rovira Email & Phone Number

HIPRA is a pharmaceutical company focused on prevention and diagnosis.My task in HIPRA is to obtain the registration authorizations for veterinary vaccines in international countries, following the applicable legislation in each case and always seeking maximum efficiency in all procedures.Job responsabilities:- To prepare registration files and obtain the registration approval.- To keep informed and updated of legislative changes.- To communicate directly with the Registration Authorities of the different countries.- To coordinate the registration work with in-house staff or distributors.- To prepare documentation and manage record variations and their maintenance.- To be responsible for the registration procedures and ensure the correct management.- To coordinate with different areas of the company involved in each case.- To contribute and implement ideas for improvement the procedures using appropriate communication channels.

Barcelona Area, Spain

Asphalion is an international consultancy that offers comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies. I worked as a Drug Safety Officer in Pharmacovigilance Department. The highlights from my role were: - Weekly global or local literature review -Handling of ICSRs and follow-up - Reporting cases to the European authorities through EudraVigilance. - Translation of information into English - Contact with Regulatory Authorities - Assistance Qualified local contact in Spain for Pharmacovigilance - Maintenance and update Pharmacovigilance System Master File (PSMF) and Standard Operating Procedures (SOP) - Write, reviewing and update pharmacovigilance agreements between companies for pharmacovigilance regulatory compliance. - Collaboration on pharmacovigilance quality assurance, audit and inspection. - Deal with the client understanding their needs and deadlines

Barcelona Area, Spain

During my Master degree I had the opportunity to work at Asphalion, an international consultancy of Pharmacovigilance, Scientific Writing and Regulatory Affairs.I was involved in the Pharmacovigilance Unit and I developed my master thesis. The project was focused on providing a global vision of a Pharmacovigilance system through the elaboration of a Pharmacovigilance System Master File.

Rotterdam, Paises Bajos

I carried out a project in the Cilia and signal transduction group of Gert Jansen.The aim of this study consisted of investigating the contribution of cilia to BMP signalling during neuronal development. The project was focused on generating a BMP-reporter knock-in cell line which would give us a tool to visualize the response of the cells when they are stimulated by BMP. Another point of the study was to design a DNA construct that allows visualization of the BMP receptor II presence in primary cilia using the CRISPR/Cas9 method.I worked for 7 months at the Department of Cell Biology of the Erasmus Medical Center and I had the opportunity to get used to work in a laboratory and to learn different techniques of cell culture, transfection of cell lines and data analysis.

Barcelona Y Alrededores, España

Internship in Systems Pharmacology Effect Control and Modeling(SPEC-M) group of Hospital Clínic de Barcelona collaborating in monitoring and data collection of anaesthetised patients.

Bachelor Of Science - Bs In Biomedical Sciences, Biomedicine

Master Of Pharmaceutical And Biotechnological Industry

Bachillerato Científico, Science