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

Coordination of pharmacokinetic Clinical Studies (phase I)

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.

- Buying immunobiological drugs and medical supplies - Receivable and payable accounts - Relationship with Pharmaceutical Industry (Support program for patient)

- 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)

Focus on Human medicine