Drug Safety Reporting Coordinator

About the Role

This remote position within the pharmacovigilance department is vital for supporting clinical research projects. You will be responsible for the smooth handling, processing, and recording of safety data. By coordinating with various internal teams, you will ensure critical safety details are managed with precision, aiding in the creation of impactful global medical treatments. This position offers a chance to participate in an international group focused on scientific progress and global wellness. You will work in a supportive atmosphere that promotes career advancement and allows you to perform work of great importance within the life sciences field. Performing well in this capacity necessitates a cooperative approach and dedication to upholding superior administrative and compliance standards within clinical research.

Requirements

• You should hold a secondary school diploma or a relevant vocational certification, supplemented by a minimum of two years of relevant professional experience, though equivalent combinations of training and experience are acceptable.
• You must be skilled in using Microsoft Office applications, specifically Word, Excel, PowerPoint, and Access.
• You are expected to possess a firm grasp of procedural documentation and demonstrate strong written and verbal communication abilities.
• You must have high-level organizational and time-management capabilities to manage concurrent tasks with focus and accuracy.
• You should be able to collaborate within a team, show strong analytical skills, and be open to occasional travel to various sites when required.

Responsibilities

• You will submit safety reports to relevant stakeholders and oversee documentation tasks, such as scanning, indexing, filing, and verifying the quality of safety reports following established procedures.
• You will gather and organize reporting data via the Clinical Trial Management System and keep internal contact directories current.
• You will handle administrative duties, including supporting audit preparation, facilitating meetings, recording minutes, and overseeing metrics and report reconciliation.
• You will instruct pharmacovigilance personnel on reporting protocols and mentor incoming administrative staff.
• You will offer filing assistance, keep physical records organized, address routine submission issues, and aid with study inventory management, including handling distributions via outside mail services.

Benefits & Perks

• This position is entirely remote and follows a typical Monday to Friday work week.
• You will be part of an international team that offers specific training and career growth paths, while engaging in significant work related to clinical research and the creation of transformative medical therapies.