Safety Reporting Specialist

Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Associate Safety Reporting Specialist – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale.

About Thermofisher

Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.

Responsibilities

• Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
• The Associate Safety Reporting Specialist assists in the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects.
• Supports management in producing project metrics as required.
• Participates in projects and programs relating to safety reporting.
• We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
• Receive, prepare, and submit safety reports to applicable parties, ensuring compliance with regulatory timelines and country legislation. • Track all expedited/periodic safety report submissions, ensuring retention of evidence of submission.
• 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/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.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 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.
• 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 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 • Ability to work effectively within a team

Benefits

• Thermo Fisher Scientific values the health and wellbeing of our employees.
• We support and encourage individuals to create a healthy and balanced environment where they can thrive.
• 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.

Below is listed the working environment/requirements for this role: • 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 Why join us?

Apply today to help us deliver tomorrow’s breakthroughs.