Clinical trial associate
Ter*** *****
Regulatory Affairs Consultant em Bluescience, Pharmaceutical Consulting
CESIF
Lisboa,
Lisboa
Este candidato está disposto a se mudar
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Experiência
Regulatory Affairs Consultant
Bluescience, Pharmaceutical Consulting
jan 2019
-
Atualmente
Clinical Trials and Regulatory Affairs Manager
Infarmed
nov 2017
-
dez 2018
Management of applications for new clinical trials; Assessment of Substantial Amendments; Management of notified information during clinical trials such as non-substantial amendments, end of trial, final report, SMR; Update of European and National clinical trials databases (EudraCT and RNEC); Specific knowledge in regulatory affairs related to human medicines and clinical trials. Management of new Marketing Authorisation Applications; Management of Marketing Authorisations renewal applications; Validation of variations submitted; Ensure the activities related to the registration, evaluation and marketing authorization for human medicines.
Pharmacist ‐ Deputy Technical Director
Farmácia Simões
mar 2004
-
fev 2017
Pharmacist Specialist; Supplied around 100 people a day; Biochemical parameters measurement; Stock management; Returns management; Psychotropic drugs management.
Pharmacist ‐ Deputy Technical Director
Farmácia Canto
jan 2003
-
mar 2004
Reviewing, monitoring and dispensing medication prescriptions; Supplied around 60 people a day; Drug compounding and management of in‐house laboratory
Formação
Master’s Degree, Clinical Trials Monitoring and Medical Affairs
CESIF
out 2017
-
out 2018
Structure of the Pharmaceutical Industry Regulatory Affairs Scientific basis in clinical research, Clinical trials monitoring Pharmacovigilance Pharmaco-economy Medical Scientific Liaison Medical Advisors and consultancy
Pharmaceutical Sciences
Instituto Superior de Ciências da Saúde Egas Moniz
out 1996
-
out 2002
Doctor of Pharmacy (PharmD)