Sr Safety Reporting Specialist

Thermo Fisher Scientific; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

Thermo Fisher Scientific seeks an experienced individual for a regulatory role focused on safety reporting. The ideal candidate will lead projects, ensure compliance with regulations, and support team development in a dynamic office environment. Join our mission to make the world healthier and safer.

Qualifications

• 5+ years’ relevant experience or equivalent knowledge, skills, and abilities.

Responsibilities

• Receives, prepares, and submits safety reports.
• Leads large scale projects ensuring compliance with regulatory timelines.
• Mentors new team members and provides input for program development.

Education

Bachelor's degree or equivalent

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Essential Functions

1. Receives, prepares and submits safety reports to applicable parties.
2. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis.
3. Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines.
4. Provides input and feedback to aid the development of program and departmental procedural documents.
5. Shares ideas and suggestions with team members.
6. Takes an active role in the development and implementation of ideas and suggestions.
7. Liaises with relevant departments around safety reporting tasks and attends various meetings as required.
8. Provides input, feedback and guidance to other team members and mentors new starters.
9. Produces metrics and has some involvement in financial projects.

Qualifications

Education and Experience: 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 5+ years’).