Drug Safety Specialist/ Sen. Drug Safety Associate
- Verfügbarkeit einsehen
- 0 Referenzen
- 50€/Stunde
- 63225 Langen (Hessen)
- Europa
- de | en | fr
- 31.08.2015
Kurzvorstellung
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
Knowledge of ICH-GCP and GVP
Consultancy in all safety related questions
Execution AE/SAE processing and regulatory reporting
Qualifikationen
Projekt‐ & Berufserfahrung
Drug Safety Expert
Kundenname anonymisiert, Friedrichsdorf
3/2015
–
5/2015
(3 Monate)
Tätigkeitszeitraum
3/2015 – 5/2015
Tätigkeitsbeschreibung
Successful consultancy, training and execution: Clinical Trial SAE processing
Successful online AE search
Successful Basecon validation support (script execution)
Successful Data Entry, - migration and migration verification (Basecon)
Systemmigration, Medizinforschung, Klinische Forschung
Über mich
Attention to details
Highly reliable
Completely committed
Diligent
Highly reliable
Completely committed
Diligent
Weitere Kenntnisse
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
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
Persönliche Daten
Sprache
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Französisch (Grundkenntnisse)
Reisebereitschaft
Europa
Arbeitserlaubnis
- Europäische Union
- Schweiz
Profilaufrufe
1159
Alter
63
Berufserfahrung
19 Jahre und 1 Monat
(seit 11/2005)
Projektleitung
3 Jahre
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