This role entailed the following:
A) Adverse events processing
- Traditional validation, processing, and management of adverse events reported world-wide spontaneously or from clinical trials whilst ascertaining SOP-compliance and study-protocol consistency, all in line with international and local Regulations (Case-management techniques, safety-data assessment, case-coding and translations from French/Spanish into English).
- Role subsequently extended to perform within-team single-case-assessment against core references, as well as periodic MedDRA-coding reviews. Also became member of the departmental case-prioritization team.
B) Compliance and Operations
- Provided case metrics/quality tracking activities, and responsible delegate for routine induction and subsequent training/coaching of new staff within team.
- Case-processing-team representative on work-groups (7 months) streamlining case-entry/coding workflows and implementing systematic case-level company-causality-assessment, and work-load/case-quality monitoring parameters.
- Single-handedly championed and delivered a qualitative analysis of the Safety-Physician-group’s performance resulting in overhauled training programs, redressed case-management/coding activities compliance and relationship improvements with case-processing teams.
C) Drug-development activities
- Clinical-development duties consisting in protocol/case-report-form/ICF reviews, blind-break, and study reconciliation activities.