Drug Safety Associate Consultant
Core
Process adverse event cases through intake, triage, data entry, quality review, and finalization for pharmaceutical and medical device partners.
Role type
Senior IC Drug Safety Case Processing Specialist
Builds
Safety databases and regulatory compliance reports for global healthcare clients
Domain
Pharmacovigilance / Drug Safety
Deliverable
client delivery
Required skills
ICH-GCP, GVP modules, 21 CFR guidelines, ARGUS database, rare disease portfolio management, case finalization, follow-up query management
Preferred skills
Training and mentoring in safety databases
Technologies
ARGUS, MS Office (Outlook, Excel, Word, PowerPoint)
Responsibilities
Intake and triage of adverse event cases from spontaneous, literature, regulatory, and clinical trial sources; Data entry and quality review of safety cases; Case finalization and distribution; Raising follow-up queries with appropriate documentation; Training and mentoring on ICSR and safety databases
Seniority
Senior, hands-on IC
