Sr Safety Reporting Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as Senior Safety Reporting Specialist – To lead and oversee the preparation of complex safety reports, ensure compliance with international pharmacovigilance regulations, and drive continuous improvement in our reporting processes to safeguard patient health.

What you’ll do

• Receive, prepare and submit safety reports to applicable parties. Ensure that all reports are compliant with regulatory timelines and country legislation and monitor this on a regular basis.
• Lead large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines.
• Provide input and feedback to aid the development of program and departmental procedural documents.
• Sharing ideas and suggestions with team members. Take an active role in the development and implementation of ideas and suggestions.
• Liaise with relevant departments around safety reporting tasks and attends various meetings as required.
• Provide input, feedback and guidance to other team members and mentors new starters.
• Produce metrics and have some involvement in financial project.

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 5+ 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

• Excellent knowledge of medical terminology
• Excellent Microsoft Office skills and good understanding of database functionality
• Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements
• Good time management and multi-tasking skills
• Strong attention to detail
• Ability to influence at all levels of the organization
• Ability to work well in a collaborative team environment
• Demonstrated initiative and utilizes persuasion and negotiation skills
• Excellent critical thinking and problem-solving abilities
• Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activities

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.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.