Safety Reporting Specialist

Work schedule

• Standard Monday-to-Friday schedule.

Role overview

What you’ll do

• Receive, prepare, and submit safety reports in line with regulatory timelines and country legislation; escalate issues when needed.
• Produce metrics and alert managers to quality or timeline issues.
• Participate in project teams and potentially lead small- to moderate-scope projects.
• Train and support team members; maintain safety reporting systems and information.
• Coordinate safety reporting tasks and client account setup with other departments.
• Participate in audits, perform testing as needed, and contribute to process improvement.

Education and experience

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Comparable relevant experience of 2+ years; an appropriate combination of education, training, and directly related experience may be accepted as equivalent.

Knowledge, skills and abilities

• Strong medical terminology knowledge; good written and verbal communication skills.
• Good Microsoft Word and Excel skills and solid understanding of safety database functionality.
• Knowledge of procedural documents and working knowledge of global safety reporting requirements, including FDA regulations and guidelines.
• Ability to multitask while maintaining quality, accuracy, and attention to detail; handle sensitive information and work effectively across the organization.
• Strong critical thinking and problem-solving skills.

Working conditions and environment

• The description states work is performed in an office, laboratory, and/or clinical environment, with possible exposure to biological fluids, infectious organisms, and electrical office equipment.
• Protective eyewear, garments, and gloves may be required.
• The description lists prolonged upright or stationary work, repetitive hand movement, frequent mobility, occasional crouching and bending, and light-to-moderate lifting up to 15–20 pounds.
• The role requires regular attendance, use of varied computer software, communication with others, multitasking, and ability to perform under stress.