Safety Reporting Specialist

Overview

The Associate Safety Reporting Specialist assists in the receipt, submission and tracking of expedited and periodic safety reports for the department's projects, and supports management in producing project metrics.

What you'll do

• Receive, prepare and submit safety reports to applicable parties, ensuring compliance with regulatory timelines and country legislation.
• Track all expedited and periodic safety report submissions, ensuring retention of evidence of submission, and alert your lead and/or line manager to any quality or timeline issues.
• Develop project management skills by acting as support to an assigned lead, and may also lead small projects.
• Liaise with relevant teams around safety reporting tasks and assist the assigned lead as required.
• Run reports and ensure that repositories and systems are maintained with up-to-date contact information.
• Provide ad hoc administrative support as and when required.
• Ensure regulatory submission files and filing processes are prepared, set up, maintained and archived as per the organization's WPDs or applicable client SOPs.
• Assist the manager in the collation of metrics.

What you'll need

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 0 to 2 years); an equivalency of education, training and/or directly related experience will be considered.
• Basic knowledge of medical terminology.
• Good written and verbal communication skills.
• Proficiency in Microsoft Office programs and a basic understanding of safety database functionality.
• Basic knowledge of procedural documents and working knowledge of global safety reporting requirements, including FDA regulations and guidelines.
• Good organizational and time management skills.
• Strong attention to detail and accuracy with an orientation toward careful and meticulous work.
• Maturity to handle sensitive information and data effectively.
• Ability to interact effectively with all levels of the organization.
• Ability to work effectively within a team.

Details

• Work schedule: standard, Monday to Friday.
• Work is performed in an office, laboratory and/or clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required, such as protective eyewear, garments and gloves.