Drug Safety Specialist (FSP) - Day 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
PV case processing, triage, peer review, adverse event assessment, regulatory reporting, data entry, coding, case review, follow-up, tracking, report preparation, audit preparation, investigator meeting support, procedure development, mentorship
Preferred skills
Medical understanding of therapeutic areas and disease states, pathophysiology knowledge, critical thinking, problem solving, English translation
Technologies
Microsoft Office (Outlook, Word, Excel), multiple databases
Responsibilities
Perform day-to-day PV activities including data entry, coding, assessment, and tracking of adverse events; Review cases for quality, consistency, and accuracy; Prepare and maintain regulatory safety reports; Assist with project implementation and coordination including presentations at client/investigator meetings; Mentor less experienced staff
Seniority
Mid-level, hands-on IC
