Clinical Safety Specialist

Quantum Leap Healthcare Collaborative; San Francisco (CA); On-site; USD 80,000 - 125,000; Full time

Job summary

Quantum Leap Healthcare Collaborative seeks a Clinical Safety Specialist in San Francisco, CA. This full-time role oversees the collection, processing, and oversight of clinical trial safety data, coordinating with Clinical Operations, Data Management, QA, and Safety Working Groups to ensure regulatory compliance.

You will review adverse events, assess seriousness and causality, enter data with MedDRA coding, and support safety deliverables, audits, and regulatory filings.

Qualifications

• Receive, review, triage, and process adverse event and other safety information from clinical trials.
• Assess seriousness, expectedness, causality, and regulatory reportability for safety issues.
• Enter and quality-check adverse event data with MedDRA coding.
• Collaborate with stakeholders to ensure regulatory compliance and safety operations.

Responsibilities

• Monitor the Clinical Safety mailbox and route information to appropriate teams.
• Support audit and inspection readiness activities and document actions.
• Prepare and support safety deliverables for regulatory filings.
• Serve as a pharmacovigilance liaison to internal and external stakeholders.

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Safety Specialist

Full Time San Francisco, CA, US 1 Attachments

Salary Range: $80,000.00 To $125,000.00 Annually

The Clinical Safety Specialist supports the collection, processing, and oversight of clinical trial safety data. The role collaborates closely with Senior Clinical Safety Specialists and cross-functional partners, including Clinical Operations, Data Management, Quality Assurance, and Safety Working Groups, to ensure regulatory compliance and alignment with departmental objectives.

GENERAL DUTIES AND ESSENTIAL JOB FUNCTIONS:

• 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 escalation 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

Attachments (1)

QLHC JD 1050 - Clinical Safety Specialist 2026SEPT.pdf