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Literature Review Specialist

2+ years
Not Disclosed
10 Nov. 11, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Operations Specialist - Literature Review & Intake

Location: Global (Remote/Flexible)
Job Type: Full-Time


About Baxter:

At Baxter, we are driven by a common mission to save and sustain lives. Whether you're working in the lab, the field, or behind the scenes, you’ll find a strong sense of purpose in everything you do. Our products and therapies are integral to hospitals, clinics, and homes around the world, directly improving patient outcomes. For over 85 years, Baxter has been at the forefront of medical innovations that transform healthcare globally.

By joining our team, you will become part of an organization where people are valued, empowered, and inspired to do their best work. This is where purpose meets passion—where you can make a real difference in the world.


Your Role:

We are looking for a Safety Operations Specialist to join our Global Patient Safety (GPS) team. In this role, you will serve as a subject matter expert for literature review and intake activities, ensuring that safety cases from literature abstracts and full-text articles are properly identified and processed. You will play a critical role in ensuring compliance with global safety regulations and contribute to maintaining patient safety across the globe.


What You'll Be Doing:

  • Literature Review: Review weekly literature abstracts to identify valid and invalid safety cases.
  • Full-Text Review: Order full-text articles when necessary, and perform detailed reviews for safety case identification.
  • Case Intake: Intake valid and invalid safety cases from literature and document them accordingly.
  • Quality Control: Perform quality control of literature reviews and case intakes, both in real-time and retrospectively.
  • Training: Lead new hire training and certification for literature review and intake processes.
  • Administrative Tasks: Order copyright materials and translations when required.
  • Follow-Up: Conduct follow-up activities for literature cases to ensure all necessary information is captured and documented.
  • Support: Assist with intake activities for cases from additional sources, as needed.

What You'll Bring:

  • Medical and Clinical Knowledge: Strong understanding of pharmacovigilance, clinical practices, and patient safety.
  • Communication Skills: Excellent oral and written communication skills for collaborating with teams and stakeholders.
  • Team Collaboration: Ability to work effectively in a team environment and contribute to collective goals.
  • Independence: Capable of working independently under tight deadlines and shifting priorities.
  • Multi-tasking: Strong ability to handle multiple tasks and prioritize daily workload.
  • Regulatory Knowledge: Familiarity with global and regional safety regulations in the pharmaceutical industry.
  • Technical Proficiency: Experience using pharmacovigilance safety systems and literature tracking tools.
  • Reading Comprehension: Strong ability to comprehend complex literature and identify relevant safety information.

Education and Experience:

  • Required:
    • Degree in Nursing, Pharmacy, Science, or an equivalent field.
    • Minimum 1–3 years of experience in pharmacovigilance, hospital patient care, or a related field preferred.
  • Preferred:
    • Experience in the pharmaceutical industry, particularly in Regulatory Affairs or Safety.

Why Baxter?

At Baxter, we are committed to fostering a culture where diversity, collaboration, and inclusion thrive. We offer a supportive work environment and a comprehensive benefits package to ensure the health and well-being of our employees. With a focus on personal and professional growth, you’ll have access to continuous learning and development opportunities to advance your career.


Reasonable Accommodations:

Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you need assistance or accommodation during the application or interview process due to a medical condition or disability, please reach out to us with your request.


Recruitment Fraud Notice:

Baxter is aware of fraudulent employment scams targeting job seekers. Please be cautious when applying and ensure you are engaging with official Baxter representatives. For more information, review our Recruitment Fraud Notice to learn how to protect yourself.


How to Apply:

Please submit your CV in English to be considered for this role.