Clinical Trial Safety Reporting Administrator - Remote

Overview

The Clinical Trial Safety Reporting Administrator is responsible for ensuring timely, accurate, and compliant submission of individual case safety reports (ICSRs) related to clinical trials.

In Short

• Coordinate the collection, tracking, and submission of ICSRs and periodic reports.
• Maintain safety reporting logs, ensuring data accuracy and completeness.
• Monitor safety reporting timelines and escalate delays or issues.
• Collaborate with clinical teams, CROs, and vendors.
• Assist in the distribution and submission of safety-related documents.
• Support audits and inspections with required documentation.
• Ensure compliance with global regulatory requirements.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• 1–3 years of experience in clinical trial safety reporting.
• Knowledge of MedDRA and WHO Drug Dictionary coding.
• Knowledge of ICH-GCP, FDA, EMA guidelines.
• Strong organizational skills and attention to detail.
• Excellent communication and interpersonal skills.
• Ability to work independently in a fast-paced environment.

Benefits

• Competitive salary.
• Opportunity for professional growth.
• Work in a dynamic team environment.
• Contribute to meaningful projects in healthcare.