Safety Reporting Coordinator

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Provide administrative safety assistance to the Pharmacovigilance department.

• Submit safety reports to relevant parties and ensure the scanning, indexing, filing, tracking, quality checks, and archiving are conducted in line with SOPs and WPDs.

• Address basic issues with submission packs.

• Collaborate with appropriate teams on administrative safety reporting tasks, ensuring audit readiness, organizing meetings, taking minutes, filing, photocopying, distributing work, reconciling reports, managing metrics, and updating systems.

• Extract and compile reporting data using the Clinical Trial Management System.

• Maintain and refresh contact lists within organizational systems.

• Assist with department and Pharmacovigilance initiatives.

• Educate Pharmacovigilance personnel on safety reporting procedures and relevant systems.

• Provide filing assistance, barcode safety reports, identify discrepancies, and uphold cleanliness and organization in the file room.

• Aid in the review of completed safety report files, audit notifications, file return alerts, and on-site audits.

• Organize study files and inventories for clients, including distribution via external postal services.

⛳️ Requirements

• High/Secondary school diploma or an equivalent qualification along with relevant formal academic or vocational credentials.

• Technical roles may necessitate a certification.

• Prior experience of at least 2 years in a comparable role.

• Equivalency may be considered through a combination of relevant education, training, and/or directly related experience.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Access).

• Strong understanding of procedural documents.

• Exceptional written and verbal communication abilities.

• Strong organizational and time management skills.

• Proven capability to manage multiple tasks simultaneously and effectively handle stress.

• Keen attention to detail and accuracy.

• Strong problem-solving capabilities.

• Ability to work collaboratively in a team and support the assigned lead and line manager.

• Occasional travel or drives to site locations may be necessary.

🏝️ Benefits

• Engaging work with a positive global influence.

• Resources available to help achieve personal career objectives.

• Opportunities for collaboration and professional growth.

• Fully remote working arrangement.

• Standard work schedule from Monday to Friday.