Safety Associate

About This Role

This home-based role is critical for ensuring the timely and accurate processing of adverse event reports related to the company's products. The Safety Associate receives, reviews, and processes incoming adverse event reports from various sources, including healthcare professionals, consumers, and regulatory agencies. The position helps ensure incoming safety information is appropriately monitored, tracked, reconciled, and routed in accordance with applicable procedures, while providing trained backup coverage for designated processes.

Responsibilities

• Monitor assigned AEI/safety mailboxes according to established procedures and coverage schedules
• Review incoming communications and identify items requiring AEI attention
• Support appropriate routing/escalation of safety-related communications to the team responsible
• Support acknowledgement and mailbox tracking activities
• Maintain mailbox organization and appropriate operational records
• Escalate unclear, urgent, or potentially non-compliant items to the appropriate AEI specialist/lead
• Perform scheduled reconciliation of designated AEI mailboxes against applicable trackers or source records
• Support identification of missing, duplicate, or potentially unprocessed communications
• Document reconciliation results according to the applicable process
• Escalate discrepancies for review and resolution
• Support follow-up and closure of reconciliation findings
• Receive, review, and triage incoming AE reports from various sources
• Create, maintain, and track case folders; file, retrieve, and distribute case folders to operations team members
• Perform ICSR surveillance on administrative topics and process including collection, reporting, follow-up processes
• Accurately enter AE data into the company's safety database
• Conduct initial case assessment and assign appropriate case status
• Track and monitor the progress of AE investigations
• Prepare case narratives and other relevant documentation
• Assist with the preparation of safety reports for regulatory submissions
• Assist in maintenance of document control storage and relevant applications/systems as directed
• Provide key input to operations team on acquisition and/or upgrade of records management application/systems
• Ensure the accuracy and completeness of all AE data
• Perform data entry and validation checks
• Maintain accurate records and documentation
• Support periodic audits and quality control checks on case processing activities
• Execute assigned activities in accordance with applicable SOPs, work instructions, and project requirements