Drug Safety Reporting Coordinator

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

📋 Description

• Provide administrative safety assistance to the Pharmacovigilance team.

• Submit expedited and periodic safety reports to relevant parties.

• Scan, index, file, archive, and conduct quality checks on safety reports in both electronic and paper formats.

• Complete safety trackers and address straightforward submission-pack issues.

• Collaborate with teams and departments on administrative safety reporting responsibilities.

• Support audit preparedness, organize meetings, take minutes, distribute work, reconcile reports, track metrics, and update systems.

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

• Maintain and refresh contact lists within organizational systems.

• Assist with department and Pharmacovigilance projects.

• Train Pharmacovigilance personnel on safety reporting procedures and related systems.

• Provide filing support, barcode safety reports, identify discrepancies, and ensure the cleanliness and organization of the file room.

• Assist with file reviews, audit notifications, file-return notifications, and on-site audits as necessary.

• Coordinate study files and inventories for clients, including external postal distribution.

• May mentor or train new administrative staff in central safety reporting.

⛳️ Requirements

• High school diploma or equivalent, along with relevant formal academic or vocational qualifications.

• Technical roles may require certification.

• At least 2 years of prior experience providing relevant knowledge, skills, and abilities.

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

• Strong teamwork capabilities and the ability to support assigned leads and line managers.

• Proficiency in Microsoft Office Programs: Word, Excel, PowerPoint, and Access.

• Solid understanding of procedural documents.

• Exceptional written and verbal communication skills, including both telephone and face-to-face interactions.

• Strong organizational and time management skills.

• Proven capability to manage paperwork and files, multitask effectively, and handle stress well.

• Keen attention to detail and accuracy.

• Strong problem-solving abilities.

• Capacity to work in an office setting with electrical office equipment.

• Occasional travel to site locations may be required.

• Flexibility to work varying hours when necessary.

🏝️ Benefits

• Fully remote work arrangement.

• Health and wellbeing support.

• Healthy and balanced work environment.

• Opportunities for collaboration and professional development.

• Reasonable accommodations for individuals with disabilities.

• Equal opportunity employment.