Sr/ Safety Reporting Specialist, Serbia

Thermo Fisher Scientific; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

Join a leading company in healthcare where your work directly impacts global health by improving drug safety through clinical trials. This role involves managing safety reports, leading projects, and collaborating with various departments, while requiring significant expertise in medical terminology and safety reporting practices.

Qualifications

• 5+ years of relevant experience in safety reporting.
• Excellent knowledge of global safety reporting requirements.
• Proven ability to mentor lower-level colleagues.

Responsibilities

• Ensure safety reports comply with regulatory timelines.
• Lead large scale projects in safety reporting.
• Provide feedback for developing procedural documents.

Skills

Medical terminology

Microsoft Office

Time management

Attention to detail

Critical thinking

Problem solving

Collaboration

Persuasion

Education

Bachelor's degree in Life-science

Tools

Database functionality

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.

Discover Impactful Work:

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

A day in the Life:

• Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis.
• Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines.
• Provides input and feedback to aid the development of program and departmental procedural documents.
• Shares ideas and suggestions with team members. Takes an active role in the development and implementation of ideas and suggestions.
• Liaises with relevant departments around safety reporting tasks and attends various meetings as required.
• Provides input, feedback and guidance to other team members and mentors new starters.
• Produces metrics and has some involvement in financial project.
• Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas.

Keys to Success:Education

Bachelor's degree in Life-science field

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).

Experience

• Excellent knowledge of medical terminology
• Excellent Microsoft Office skills and good understanding of database functionality
• Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements
• Good time management and multi-tasking skills
• Strong attention to detail
• Ability to influence at all levels of the organization
• Ability to work well in a collaborative team environment
• Demonstrated initiative and utilizes persuasion and negotiation skills
• Excellent critical thinking and problem solving abilities
• Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting 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.

Apply today! http://jobs.thermofisher.com

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.