Drug Safety Specialist/ Sen. Drug Safety Associate

Long term experienced Drug Safety Specialist/ Sen. Drug Safety Associate
Knowledge of ICH-GCP and GVP
Consultancy in all safety related questions
Execution AE/SAE processing and regulatory reporting

• Windows 7
• Windows 8

Attention to details
Highly reliable
Completely committed
Diligent

Consultancy, training and execution: AE/ SAE processing (Clinical Trials and post-marketing)
Project set-up
Regulatory reporting (Gateway/ EVWEB; ICSR and cumulative reports)
Online AE search
Query Management
Safety-database: Data Entry, Data Coding, Data Migration and Migration Verification
Review and/or generation of procedures
Coordination of audit/ inspection preparations
Safety Training/ Mentoring/ Quality Review
Medical writing and translations
Safety presentations
First point contact and resource on safety related questions for investigational sites, sponsors, DSAs, CRAs, CPMs

Coding Skills: MedDRA, WHO, ICD 10, ATC:Excellent
IT Skills: MS-Office: Advanced
Languages: German:Native
English: Fluent
French: Basic
Safety Databases: ARISgTM, Basecon: Excellent
E-CRFs: RAVE, Inform, Oracle: Excellent