Safety Reporting Coordinator - Cambridge, UK

Safety Reporting Coordinator - Cambridge, UK – Flex Office-Based (2-3 days Home-Based)

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.

Location/Division Specific Information

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

Discover Impactful Work:

At PPD, we hire the best, develop ourselves and each other, and recognise the power of being one team. We offer continued career advancement opportunities, award-winning training and benefits focused on the health and wellbeing of our employees.

A Day in the Life:

Safety Reporting Administrator’s provides administrative safety support to the safety reporting team and Pharmacovigilance department. Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects. Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues. May also be involved in updates to procedures and other initiatives related to safety reporting. May mentor or train new central safety reporting staff.

Essential Functions:

• Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation.
• Assists in producing metrics and alerts manager to any quality or timeline issues.
• Ensures timely maintenance of safety reporting systems and information.
• Liaises with various departments and external parties (including clients) in relation to safety reporting tasks and the setting up and maintenance of projects.
• Good understanding of SOPs, GDs and project related documentation.
• Proactively troubleshoots daily operational issues with limited input from management.
• With support of management, provides updates to the operational safety reporting team and Senior Management in relation to work deliverables / status as required and in accordance to regulatory requirements.
• Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
• Responsible for training Pharmacovigilance department staff on the safety reporting process and various systems associated with safety reporting.
• Assists with, and may participate in, audit and inspection preparation if required or requested by the company or client.
• Knowledge of, and ability to perform against, critical metrics for projects. Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.

Keys to Success:

Education and Experience:

• 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.

Skills and Abilities:

• Ability to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks
• Ability to work effectively as an individual and independently to attain the wider goals of the team.
• Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint)
• Good knowledge of Pharmacovigilance and industry terminology
• Strong written and verbal communication skills, including telephone conversations as well as face to face interaction internally within the department
• Ability to identify and prioritise tasks simultaneously along with handling numerous deadlines and stay focused during these times
• Ability to work under pressure without jeopardising work standards
• Ability to interact effectively with all levels of the organization
• Possess the maturity to handle sensitive information and data effectively
• Strong knowledge of procedural documents with the ability to identify gaps in processes and offer constructive suggestions for solutions
• Strong attention to detail, strong organization, and time management skills with proven ability to handle multiple tasks at once and deal effectively with pressure
• Ability to apply knowledge, skills, and expertise to assist other colleagues in safety reporting activities
• Able to commute to the office 2-3 times per week.

Work 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
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritising and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.