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
Drug Safety Specialist (Pharmacovigilance)
Builds
Regulatory safety reports and safety information tracking for pharmaceutical and biotech clients
Domain
Pharmaceutical / Biotechnology / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Adverse event assessment, regulatory reporting, data coding, case review, medical understanding of therapeutic areas, critical thinking, attention to detail, prioritization
Preferred skills
Mentorship, audit preparation, investigator meeting coordination, on-call duty management
Technologies
Microsoft Office (Outlook, Word, Excel), multiple databases
Responsibilities
Collect, monitor, assess, evaluate, research, and track safety information; review cases for quality and accuracy; prepare regulatory safety reports; coordinate project implementation and attend client/investigator meetings; assist in procedure development and audits.
Seniority
Mid-level, hands-on IC
