Senior/Principal Drug Safety Specialist (Night Shift)
Core
Perform and oversee day-to-day Pharmacovigilance (PV) activities including collection, monitoring, assessment, evaluation, research, and tracking of safety information in a highly regulated environment.
Role type
Senior/Principal Drug Safety Specialist (Pharmacovigilance)
Builds
Safety information processing and regulatory compliance for pharmaceutical and biotech clients
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance case management, regulatory compliance, therapeutic area knowledge, critical thinking, clinical study administration, budget forecasting, audit preparation, mentorship, global regulatory requirements understanding, prioritization
Preferred skills
None explicitly stated
Technologies
Microsoft Office (Outlook, Word, Excel), multiple databases
Responsibilities
Perform day-to-day PV activities independently, operate in a lead capacity to develop procedural documents, review regulatory publications, review cases for quality and accuracy, coordinate routine project implementation and client meetings, mentor less experienced staff
Seniority
Senior, hands-on IC with lead capacity
