Safety Reporting Specialist

Lensa; United States; On-site; USD 44,000 - 70,000; Full time

Job summary

Thermo Fisher Scientific is looking for an Entry-level Safety Reporting Specialist to ensure accurate submission and tracking of safety reports. Join a mission-driven team with a commitment to health, safety and innovation. This full-time position involves collaborating across departments and engaging in significant research contributions.

Benefits

Competitive remuneration

Annual incentive plan bonus

Healthcare benefits

Qualifications

• Education: Bachelor's degree or equivalent qualification.
• Experience: Previous experience comparable to 2+ years in a related field is preferred.
• Knowledge of global safety reporting requirements is advantageous.

Responsibilities

• Responsible for receipt and submission of safety reports while ensuring compliance with timelines.
• Assists in producing project metrics and alerts management on quality issues.
• Liaises with various departments on safety reporting tasks.

Skills

Strong knowledge of medical terminology

Good written and verbal communication skills

Strong critical thinking and problem-solving skills

Attention to detail and accuracy

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

Job description

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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. Our detailed, goal-oriented Pharmacovigilance colleagues 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. As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services. Discover Impactful Work: As a Safety Reporting Specialist, you will be responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. You will assist management in producing project metrics as required. You will also be involved in projects and programs relating to safety reporting and may take a lead role on projects. A day in the Life:

• 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.
• Participates on project teams and may lead projects of small to moderate scope. Provides training and support to other team members.
• Performs administrative tasks such as filing and the maintenance of safety reporting systems and information.
• Liaises with various departments around safety reporting tasks and the setting up of client accounts.
• Participates in audits where required and performs testing activities as needed.
• Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives. Keys to Success: Education
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification Experience
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 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
• Strong knowledge of medical terminology
• Good written and verbal communication skills
• Good Microsoft Word and Excel skills and solid understanding of safety database functionality
• Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines)
• Ability to juggle multiple tasks while still delivering high quality results
• Strong attention to detail and accuracy with orientation toward careful and meticulous work
• Possess the maturity to handle sensitive information and data effectively
• Ability to interact effectively with all levels of the organization
• Strong critical thinking and problem-solving skills 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:
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.) Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
  
  

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. 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.

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.

If you have questions about this posting, please contact [e-mail]

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  IT Services and IT Consulting

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