Principal Safety Reporting Specialist - FSP

Work Schedule

Environmental Conditions

Job Description

Join Us as a Principal Safety Report 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. 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 Report Specialist is responsible for overall planning, co-ordination and delivery of safety reporting for large and complex projects. Leads complex projects and programs, including full project oversight and maintenance of metrics, compliance, and finances. Recommends updates to procedures, regulatory intelligence activities and other initiatives related to safety reporting. Provides training and support to other team membersand serves as primary point of contact in the absence of the 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:
• Receive, prepare, and submit safety reports to applicable parties, ensuring compliance at all stages.
• Identify and resolve any quality or timeline issues and keep your Manager informed of progress. Exercise independent judgment to troubleshoot, resolve project issues, and identify areas for improvement.
• Lead and monitor large and complex projects effectively to ensure that all aspects of the project are completed successfully and on time.
• Attend and present at various meetings as required.
• Facilitate and advise on company, client, and regulatory audits where required.
• Provide training and support to lower-level team members, mentor new starters, provide input on individual performance, and share ideas and suggestions with team members.
• Work with the manager to collate metrics, analyze compliance metrics, and provide recommendations on updating financial systems.

Education and Experience 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 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:
• Advanced knowledge of medical terminology
• Excellent Microsoft Office skills and understanding of database functionality
• Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements
• Posses critical thinking and problem-solving abilities
• Demonstrated ability to lead, mentor and motivate others
• Ability to work well in a collaborative team environment
• Strong attention to detail with ability to work with ambiguity and complexity
• Ability to work effectively within a team to attain a shared goal
• Demonstrated initiative and utilizes persuasion and negotiation skills to complete assigned tasks, delegating effectively where required
• Ability to apply advanced knowledge, skills, and expertise to communicate and assist internal clients

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/ 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?
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.