Drug Safety Specialist (Night Shift)
Core
Perform day-to-day Pharmacovigilance (PV) activities including data entry, coding, assessment of adverse events, case review, follow-up, tracking, and regulatory reporting to ensure patient safety.
Role type
Senior IC drug safety specialist (pharmacovigilance)
Builds
Regulatory safety reports and PV case files for pharmaceutical and biotech clients
Domain
Life sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Adverse event assessment, regulatory reporting, case review, data coding, therapeutic area knowledge, critical thinking, prioritization, audit preparation, stakeholder coordination
Preferred skills
Mentorship, procedure development, on-call management
Technologies
Microsoft Office (Outlook, Word, Excel), multiple safety databases
Responsibilities
Collect, monitor, assess, evaluate, research, and track safety information; review cases for quality and accuracy; prepare regulatory safety reports; coordinate PV activities with project teams, clients, and investigators; assist in audit and meeting preparations; mentor less experienced staff.
Seniority
Mid-level, hands-on IC with mentorship responsibilities
