Janaina Scaramelo Silva
Angestellt, Global Pharmacovigilance Specialist, Bencard Allergie GmbH
München, Deutschland
Werdegang
Berufserfahrung von Janaina Scaramelo Silva
I worked for 2 years as Pharmacovigilance Data Entry Officer and since 1 year I have worked in a Global Pharmacovigilance Management Team. Main responsibilities: - PSMF update - PV Agreements implementation - Communication with LSOs (Local Safety Officers) - Overview and evaluation of KPIs and Non-conformances
- Case processing (database LSMV): spontaneous, non-interventional studies and from literature search - ICSR quality check - Follow-up of safety data - Case submission to Competent Authority (EMA) according to deadline - MedRA terminology - Case Processing Management Deputy
1 Jahr und 7 Monate, Dez. 2019 - Juni 2021
Clinical Research Associate
APEX Research GmbH
Coordination of pharmacokinetic Clinical Studies (phase I)
7 Jahre und 9 Monate, Juni 2011 - Feb. 2019
Clinical Trials Study Coordinator
Hospital de Clínicas da UFPR
Mainly responsabilities: - Data entry in Case Report Form (CRF/EDC) - Safeties submission - Therapeutic research area: Hematological diseases (Chronic Myeloid Leukemia – phases II and III; Myelofibrosis and Lymphoma (phase III). Studies sponsored by pharmaceutical companies.
3 Jahre und 5 Monate, Juli 2012 - Nov. 2015
Office Administrator
CENTRA
- Buying immunobiological drugs and medical supplies - Receivable and payable accounts - Relationship with Pharmaceutical Industry (Support program for patient)
4 Jahre und 7 Monate, Mai 2007 - Nov. 2011
Clinical Trials Study Coordinator
Centro Médico São Francisco
- Data entry in CRF (EDC) - Follow-up of SAE, Adverse events and concomitant medications - Description and submission of protocol deviation to Ethics Committee - Study medication dispensation and accountability - Therapeutic research area: HIV/AIDS (phases II, III and IV; one of them audited by FDA, with no major findings); Anti-Influenza vaccine (phases III and IV); Hepatitis B (phase III); Herpes Zoster vaccine (phase III)
Ausbildung von Janaina Scaramelo Silva
1 Jahr und 10 Monate, März 2015 - Dez. 2016
Business Administration
Universidade Positivo
3 Jahre und 10 Monate, März 2001 - Dez. 2004
Biomedicine
Universidade Estadual Paulista Júlio de Mesquita Filho
Focus on Human medicine
Sprachen
Portugiesisch
Muttersprache
Englisch
Gut
Deutsch
Gut
Spanisch
Grundlagen