Safety Reporting Specialist

Overview

Manage and coordinate the production of regulatory and safety reports, ensuring accurate and timely documentation of adverse events and supporting compliance with global pharmacovigilance requirements.

What you'll do

• Receive, prepare and submit safety reports to applicable parties, escalating to lead and/or line manager if any issues are encountered.
• Ensure reports are submitted in compliance with regulatory timelines and country legislation.
• Assist in producing metrics and alert managers to any quality or timeline issues.
• Participate in project teams and may lead projects of small to moderate scope.
• Provide training and support for other team members.
• Perform administrative tasks such as filing and the maintenance of safety reporting systems and information.
• Liaise with various departments around safety reporting tasks and the setting up of client accounts.
• Participate in audits where required and perform testing activities as needed.
• Share ideas and suggestions with team members, ensuring effective communication, and participate in process improvement initiatives.

What you'll need

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient.
• Strong knowledge of medical terminology.
• Good written and verbal communication skills.
• Good Microsoft Word and Excel skills and solid understanding of safety database functionality.
• Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines).
• Ability to juggle multiple tasks while still delivering high quality results.
• Strong attention to detail and accuracy with orientation toward careful and meticulous work.
• Maturity to handle sensitive information and data effectively.
• Ability to interact effectively with all levels of the organization.
• Strong critical thinking and problem-solving skills.

Details

• Work schedule: standard, Monday to Friday.
• Work is performed in an office/laboratory and/or clinical environment, with exposure to biological fluids and potential exposure to infectious organisms; personal protective equipment such as protective eyewear, garments and gloves is required.
• Physical requirements include working upright and/or stationary for 6-8 hours per day, repetitive hand movements, frequent mobility, occasional crouching and stooping, and light to moderate lifting and carrying up to 15-20 lbs.
• Regular and consistent attendance required.