Principal Safety Reporting Coordinator

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Join Us as a Principal Safety Reporting Coordinator – 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. 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. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. The Principal Safety Reporting Coordinator provides overall planning and coordination of large and complex projects relating to safety reporting. Leads complex projects including full project oversight and maintenance of metrics. Recommends updates to procedures and other initiatives related to safety reporting. Provides training and support to safety reporting admin team members, and serves as back up in the absence of line manager. 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. What You'll Do:

• Responsible for the submission of safety reports to applicable parties, including subsequent scanning, indexing and filing (both electronic and paper), safety tracker completion and quality check, and archiving in accordance with SOPs and WPDs. Resolve complex issues with submission packs through discussion with Safety Specialists or Safety Reporting Specialists, with minimal supervision.
• Provide support when required in the receipt and preparation of safety report submissions, including log sheet or electronic system entry, cover letter, and third-party email preparation.
• Provide lead assistance and direction to team members and liaise with relevant departments on a range of administrative safety reporting tasks, including audit readiness activities, develop training materials, meeting organization, minute taking, filing, photocopying, work distribution, reconciling reports, end-of-day emails, assisting in project management activities, authoring and reviewing other Safety Administrator deviations, updating the organization's systems with project allocation.
• Responsible for extracting and collating reporting information via the Clinical Trial Management System, maintain and update contact lists on the organization's systems as required by Safety Specialist or Safety Reporting Specialists. Troubleshoot and provide support to the team on arising issues.
• Lead department and Pharmacovigilance initiatives as relevant.
• Provide training to Pharmacovigilance department staff on the Safety Reporting process and procedures, updates to the organization's systems, and develop training material.
• Demonstrate initiative and utilize persuasion and negotiation skills to complete assigned tasks, delegating effectively where required.
• Assist when required to provide filing support for multiple projects, including barcoding of safety reports, filing of safety reports, identification and reporting of any problems and inaccuracies to management, as well as responsibility for the file room in terms of cleanliness and organization.

Education and Experience Requirements:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 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, Abilities:

• Demonstrated leadership qualities with the ability to assist in the management of a large and/or global project
• Excellent critical thinking and problem solving skills with the ability to negotiate and persuade others on solutions to problems
• Ability to work effectively in a team to attain a shared goal as well as independently
• MS Office (Word, Excel, PowerPoint, Access) and database experience
• Must be self-motivated with a positive attitude and an ability to work well with others, as well as motivate other team members
• Excellent written and verbal communication skills, including telephone conversations as well as face-to-face interaction
• Excellent organization and time management skills, with the ability to delegate to others
• Excellent attention to detail and accuracy with orientation towards careful and meticulous work, with proven ability to handle multiple tasks at once and deal effectively with stress
• Ability to work independently and with minimal supervision

Working Environment: 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. Below is listed the working environment/requirements for this role:

• Work is performed in an office environment with exposure to electrical office equipment
• Potential drives to site locations and/or travel required on rare occasion
• Majority of work computer-based
• Long varied hours required on occasion

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 breakthroughs. Apply To This Job