HEALTH INFORMATICS SPECIALIST

Job Description

Requirements

• • 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)
• Bachelor’s degree in pharmacy, Medicine, Health Informatics with 2 years of experience or Masters degree.