Safety Specialist
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 pharmacovigilance specialist
Builds
Regulatory safety reports and PV case files for pharmaceutical and biotech clients
Domain
Life sciences / Pharmacovigilance
Required skills
Adverse event assessment, regulatory reporting, case review, data coding, therapeutic area knowledge, critical thinking, attention to detail, project coordination, audit preparation, mentorship
Preferred skills
None stated
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 preparation and audits; mentor less experienced staff
Seniority
Mid-level, hands-on IC
