Senior Safety Specialist
Core
Perform and oversee day-to-day Pharmacovigilance (PV) activities including collection, monitoring, assessment, evaluation, research, and tracking of safety information to ensure patient safety in a highly regulated environment.
Role type
Senior individual contributor pharmacovigilance specialist
Builds
Safety information processing and regulatory compliance for pharmaceutical and biotech clients
Domain
Life sciences / Pharmacovigilance
Required skills
Pharmacovigilance operations, regulatory compliance, therapeutic area knowledge, case review and quality assurance, clinical study administration, budget forecasting, audit preparation, mentorship, critical thinking, data management
Preferred skills
None stated
Technologies
Microsoft Office (Outlook, Word, Excel), multiple databases
Responsibilities
Perform day-to-day PV activities independently; provide leadership in procedural document development; review regulatory publications and maintain therapeutic area expertise; review cases for quality and accuracy; coordinate project implementation and committee meetings; mentor less experienced staff
Seniority
Senior, hands-on IC with mentorship responsibilities
