HEALTH INFORMATICS SPECIALIST

• Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners within study specified timelines. • Perform intake, data entry, and triage of individual case safety reports (ICSRs) into safety databases. • Perform peer / independent QC of Safety reports as needed. • Create and maintain high-quality standard response documents (SRDs), slide decks, and FAQs aligned with the latest clinical updates and customer needs. • Represent Medical Information in global matrix teams and contributed to the Core Medical Plan (CMP) by identifying key trends and clinical data gaps from inquiry analysis. • Contribute to process optimization initiatives, identifying and resolving operational inefficiencies across global MI workflows. • Work with Data Management and clients on reconciliation of safety databases. • Deliver internal training on SOPs, and regulatory expectations to cross-functional teams and new hires. • Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs)