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)