Drug Safety Reporting Specialist (Night Shift)

Lensa; United States; On-site; USD 80,000 - 115,000; Full time

Job summary

A leading career site is seeking a Drug Safety Reporting Specialist for night shifts. You will manage safety reports and ensure compliance with regulations while working in a collaborative environment. The role requires excellent knowledge of medical terminology and strong communication skills. Join a top-tier organization and contribute to critical safety reporting initiatives.

Qualifications

• A Bachelor’s degree or equivalent qualification is required.
• 2+ years of relevant experience in a similar role.

Responsibilities

• Receives, prepares, and submits safety reports complying with regulatory timelines.
• Assists management in producing project metrics and addresses quality issues.
• Provides training and support to team members.

Skills

Medical terminology

Written communication skills

Verbal communication skills

Microsoft Word

Microsoft Excel

Safety database functionality

Critical thinking

Problem solving

Attention to detail

Education

Bachelor's degree or equivalent

Job description

Drug Safety Reporting Specialist (Night Shift)

Drug Safety Reporting Specialist (Night Shift)

3 days ago Be among the first 25 applicants

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Lensa is the leading career site for job seekers at every stage of their career. Our client, Thermo Fisher Scientific, is seeking professionals. Apply via Lensa today!

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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. 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.

A Day In The Life

• Receives, prepares and submits safety reports to applicable parties. Raises 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.
  
  

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’)
  
  

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.
• Proven knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines)
• Ability to balance 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 optimally
• Ability to interact effectively with all levels of the organization
• Strong critical thinking and problem solving skills
  
  

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.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  IT Services and IT Consulting

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