Job Description
Join us as Safety Reporting Specialist – To manage and coordinate the production of regulatory and safety reports, ensure accurate and timely documentation of adverse events, and support compliance with global pharmacovigilance requirements.
What You'll Do:
•Receive, prepare and submit safety reports to applicable parties. Escalate 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 alerts 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.
•Participating in audits where required and performing testing activities as needed.
•Share ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
Education and Experience:
•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 for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
•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
•Possess the 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
Working Conditions and Environment:
•Work is performed in an office/laboratory and/or a 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.
Physical Requirements:
•Ability to work in an upright and/or stationary position for 6-8 hours per day.
•Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
•Frequent mobility required.
•Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
•Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
•Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
•Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
•Frequently interacts with others to obtain or relate information to diverse groups.
•Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
•Regular and consistent attendance.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
