Please enable JavaScript.
Coggle requires JavaScript to display documents.
SARM Deep Dive - Coggle Diagram
SARM Deep Dive
Signal Management
Signal surveillance strategy
Internal safety database review
Statistical disproportionate analysis
Tracking potential and validated signals
Analysis of signal; Signal assessment report
PRAC Meeting minutes surveillance
Aggregate Reports
PBRERs/PSUR
PSUR-MDR
PADERs
CARs
ACOs (PM section)
IND/NDAs - PM
DSURs
Risk Management
Coordinate RMP generation
RMP annual review
Ad Hoc Requests
Health hazard evaluations
Safety Analysis Request from
Health Authority/Internal Stakeholders
Support Label Updates
Response to Safety documents
Assessment Reports
Own CAPAs
Compliance Support
Audits and Inspections
Support metrics evaluation
Other Responsibilities
Review SMPs
Review PVAs
Line Listings
PSMF Contributions
PV Intelligence: Review new Regs
Change control meeting
QMS Presentations
Presentations for quality
Signal Detection Oversight
Update SOPs, WIs, Templates etc.
Participate in external workstreams
Database enhancements