Drug Safety Reporting Coordinator

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a 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 Safety Reporting Coordinator provides administrative safety support to the Pharmacovigilance department. Specifically in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. This includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks. Involved in projects relating to safety reporting. May mentor or train new central safety reporting admin staff. 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 simple problems with submission packs with minimal input from your manager or other administrators. Provide assistance and liaise with relevant teams and departments on a various range of administrative safety reporting tasks, including audit readiness activities, meeting organization, minute taking, filing, photocopying, work distribution, reconciling reports, end of day emails, completing metrics and 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. Support department and Pharmacovigilance initiatives as relevant. Responsible for training Pharmacovigilance department staff on the safety reporting process and various organization's systems associated with safety reporting. 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 organisation. Assist with file reviews for completed safety reports, maintain audit notification and file return notification forms and provide assistance with on-site audits if required or requested by the organization or client. Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed. 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 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, Abilities: Know how to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint, Access) and solid knowledge of procedural documents Excellent written and verbal communication skills, including telephone conversations as well as face to face interactions with all levels of the organization Excellent organization and time management skills, including those of paperwork and files, with proven ability to handle multiple tasks at once and deal effectively with stress Strong attention to detail and accurate with orientation towards careful and meticulous work Strong problem solving skills 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.