Dr. Aline Taveira

Local Risk Management Plans (RMP) Manager • Management of implementation of RMP commitments and educational materials. • Training of country staff on RMP product key safety messages in educational materials. • Training of local staff involved in implementation of RMPs. • Assistance of Swiss departments for alignments of all local functions in support of RMP commitments implementation.

Patient Safety Specialist • Subject-matter expert for non-interventional studies and for local / global projects in the field of social media campaigns and digital projects. • Reporting, submission and distribution of safety information to local health authorities. • Preparation of and participation in internal and external audits. • Training of internal and external associates on pharmacovigilance procedures.

• Liaised with both internal and external vendors (clients, HCPs and patients). • Assisted in the preparation of plans as required. • Processed and evaluated AE reports: performed seriousness rating, causality and expectedness assessment. • Review/Quality check of source documents, coding, data entry, report generation and distribution.

• Adverse events case processing. • EudraVigilance (EVWEB) / FDA Safety Reporting Portal submission. • Assessment of potential ICSR in literature abstracts. • Ensured quality and accuracy of data used to support regulatory documents.

PhD student, thesis advisor: Prof. Dr. med. Nicolas Müller • Defined problems, identified possible causes and implemented solutions. • Understood and synthesized large quantities of data. • Prepared grant progress reports and published in scientific journals. • Reviewed and evaluated internal and external work (Peer-Review).

Supervised students in the Biology department, making sure they understood and completed their practical work on time.

Undergraduate research studying the impact of Borna disease virus on chromatin remodeling of the central nervous system in Dr. Daniel Dunia’s laboratory.

Undergraduate research studying the induction of allograft tolerance by CD4+ CD25+ T regulator lymphocytes in Prof. Joost van Meerwijk’s laboratory.

Drug development, ICH Guidelines, toxicology studies, risk assessment, signal detection