Clinical Safety Specialist: Pharmacovigilance & Data Integrity

ADP, Inc.; San Francisco (CA); On-site; USD 80,000 - 125,000; Full time

Job summary

ADP, Inc. is seeking a Clinical Safety Specialist in San Francisco, CA to support collection, processing, and oversight of clinical trial safety data. The role collaborates with cross-functional teams to ensure regulatory compliance and alignment with departmental objectives.

The incumbent will review adverse events, assess causality and seriousness, and maintain safety databases with clear narratives. Strong collaboration with Clinical Operations, Data Management, QA, and Safety Working Groups

Qualifications

• Experience working with pharmacovigilance processes and safety data management.
• Ability to triage adverse events and assess seriousness, expectedness, and causality.
• Experience with regulatory reporting timelines and SOPs.

Responsibilities

• Receive, review, and process adverse event and safety information from clinical trials.
• Perform initial assessments of seriousness, expectedness, causality, and reportability; escalate as needed.
• Enter, maintain, and quality-check adverse event data with accurate MedDRA coding.
• Identify missing or unclear safety information and follow up with sites and partners.
• Monitor safety mailbox daily to ensure timely receipt, acknowledgement, triage, and routing of information.

Job description

ADP, Inc. is seeking a Clinical Safety Specialist in San Francisco, CA to support collection, processing, and oversight of clinical trial safety data. The role collaborates with cross-functional teams to ensure regulatory compliance and alignment with departmental objectives.

The incumbent will review adverse events, assess causality and seriousness, and maintain safety databases with clear narratives. Strong collaboration with Clinical Operations, Data Management, QA, and Safety Working Groups