Full range of PV services
QP PV
Signal detection and other PV obligations
Risk Management Planning
QP PV and Deputy Services
Setting up of PSMF and PV departments
24/7 Medical Cover
Compliance monitoring
Audits and Inspections
PBRER/PSUR development
DSUR development
PADERs
Responses To Questions
Non-EU Periodics
Risk Management Planning
Signal detection and other PV obligations
Risk Management Planning
Development of EU RMPs
Development of DHPC and other risk mitigation activities
Development of REMS
Monitoring the effectiveness of RMPs/REMS
Oversight of PASS/TSS
Development of BRMPs
Monitoring the Benefit Risk profile of drugs
Signal detection and other PV obligations
Signal detection and other PV obligations
Signal detection and other PV obligations
Robust Signal Detection
Safety Analysis
Medical review of new signals
Labelling issues
Development of CCSI / SmPC / PIL
Safety boards
Oversight of Studies
MAA and NDA submission support
Safety Overviews
Clinical Expert Statements
Medical Info set-up and queries