Clinical Safety Specialist: Pharmacovigilance & Safety Data

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

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.