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About the Role
The Clinical Safety Specialist supports the collection, processing, and oversight of clinical trial safety data. This role collaborates closely with Senior Clinical Safety Specialists and cross-functional partners to ensure regulatory compliance and alignment with departmental objectives.
Responsibilities
- Receive, review, triage, and process adverse event and other safety information from clinical trials in accordance with applicable regulatory requirements, QLHC SOPs, Work Instructions, and project-specific plans.
- Perform initial assessments of seriousness, expectedness, causality, and regulatory reportability, escalating safety issues per defined governance and escalation pathways.
- Enter, maintain, and quality-check adverse event data in the QLHC safety database, including accurate MedDRA coding and clear, concise, and compliant case narratives.
- Proactively identify missing, inconsistent, or unclear safety information and conduct documented follow-up via written or verbal communication with study sites, monitors, or partners.
- Monitor and manage the Clinical Safety mailbox daily to ensure timely receipt, acknowledgment, triage, and routing of safety information in compliance with regulatory timelines and internal procedures.
- Ensure all safety mailbox communications are appropriately documented, tracked, and actioned, including coordination of follow-up with study sites, partners, and internal functions.
- Serve as a pharmacovigilance liaison and resource to internal and external stakeholders, including Clinical Operations, Data Management, Quality Assurance, Safety Working Groups, and clinical sites, as delegated.
- Support Safety Working Group activities, including agenda preparation, material compilation, safety issue tracking, and documentation of discussions, decisions, and action items.
- Collaborate with Senior Clinical Safety Specialists to support reconciliation between clinical and safety databases and resolution of discrepancies in a timely and traceable manner.
- Support delivery of routine and ad hoc safety deliverables to pharmaceutical partners in accordance with applicable Safety Data Exchange Agreements and contractual timelines.
- Contribute to the preparation, review, and submission of safety sections of annual reports, regulatory filings, and other periodic safety deliverables, as assigned.
- Support audit and inspection readiness activities, including document preparation, response drafting, and implementation of follow-up actions under supervision.
- Maintain compliance with SOPs and Work Instructions. Identify and escalate process gaps, risks, or improvement opportunities to support a robust and sustainable safety operation.
- Participate in daily Clinical Safety team meetings to provide case status updates, flag risks or delays, align on priorities, and support timely decision-making and workload management.
- Perform other safety-related duties as assigned to support departmental objectives and operational continuity.