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 / Regulatory Compliance
Required skills
Pharmacovigilance activities, Adverse event assessment, Regulatory reporting, Data entry and coding, Case review, Medical knowledge of therapeutic areas, Critical thinking, Attention to detail
Preferred skills
Experience with Clinical Trials, Endpoint Assessment Committee, Data Safety Monitoring Committee, Mentoring staff
Technologies
Microsoft Office (Outlook, Word, Excel), Multiple databases
Responsibilities
Collect, monitor, assess, evaluate, research, and track safety information; Review cases for quality, consistency, and accuracy; Prepare and maintain regulatory safety reports; Coordinate project implementation and attend meetings; Mentor less experienced staff
Seniority
Mid-level, hands-on IC
