Safety/Pharmacovigilance

Capabilities & Skills

Advisory Committee Participant/Panelist

Aggregate Safety Data Review & Analysis

Auditing

Benefit/Risk Assessments

Business Relationships

Clinical Development Strategy

Compliance/Metrics

Computer Systems

Crisis Management/Recalls

Data Monitoring Committees

Due Diligence Evaluations

Epidemiology

Evaluation of Product Complaints (HHA/HHE)

Expedited Reporting

Individual Case Review (SAEs)

Integrated Safety Summaries For Submissions

MAUDE Reporting

Patient Registries

Periodic Reporting – DSUR

Periodic Reporting – PBRER

Periodic Reporting – PSUR

Post-Market Surveillance

Regulatory Requirements (GPvP)

Risk Mitigation/REMS

Safety Communications

Safety Labeling

Signal Detection/Evaluation

SOPs

Training