Safety Surveillance Physician
Core
Implement and support proactive product surveillance strategies by performing alert triage, signal validation, and analysis of safety data to identify potential safety signals.
Role type
Safety Surveillance Physician (Standard)
Builds
Product-specific medical safety strategies and safety data analysis outputs
Domain
Pharmaceutical medicine / Pharmacovigilance
Required skills
Pharmacovigilance concepts, regulatory requirements knowledge, safety data analysis, complex data interpretation, scientific presentation, Microsoft Office Suite, attention to detail
Preferred skills
Board certification, clinical experience, pharmaceutical medicine experience, Master's/PhD
Technologies
Safety databases, health authority databases, product quality databases, computer-assisted analysis tools
Responsibilities
Perform alert triage within pre-defined timelines, conduct systematic reviews of cases and aggregate data, review trends to identify potential safety signals, validate and evaluate signals, develop and implement post-marketing surveillance strategies, participate in matrix teams for product-specific safety, track signal disposition, maintain documentation for signal detection and management
Seniority
Standard (entry to mid-level)