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2+ years
Not Disclosed
10 Oct. 14, 2024
Job Description
Job Type: 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 Description

About Thermo Fisher Scientific Inc.

Thermo Fisher Scientific Inc. is a global leader in the life sciences sector, providing top-tier solutions to pharmaceutical companies, biotech firms, and Clinical Research Organizations (CROs). As a trusted partner to some of the most innovative companies in the industry, we offer exceptional opportunities for experienced Safety Writers to engage in exciting projects across diverse therapeutic areas.

Job Description

As a Safety Writer at Thermo Fisher Scientific, you will play a key role in delivering high-quality scientific and medical writing services. You will collaborate within project teams to provide outstanding customer service and ensure successful project execution. Your responsibilities will include:

  • Understanding, interpreting, analyzing, and presenting complex data
  • Writing concise and clear reports and documents
  • Managing multiple reports simultaneously and prioritizing tasks to meet strict deadlines
  • Facilitating meetings and managing the review and comment resolution stages of document preparation
  • Interacting directly with clients to provide exceptional service

Job Requirements

To qualify for this position, you must possess the following qualifications:

  • Bachelor’s degree or higher in a scientific discipline
  • Excellent written and verbal English communication skills
  • Advanced knowledge of the Microsoft Office suite
  • Experience in task-based project management and client interaction
  • Strong understanding of aggregate safety report writing guidelines, clinical trial processes, and post-marketing pharmacovigilance
  • Preferably, experience in authoring device aggregate safety reports or clinical evaluation reports

Additionally, you should have a minimum of two years’ experience in authoring two or more of the following report/document types for medicinal products:

  • Development Safety Update Reports (DSURs)
  • Periodic Benefit Risk Evaluation Reports (PBRERs) / Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PA(D)ERs)
  • Risk Management Plans (RMPs)

Our Offer

At Thermo Fisher Scientific, we provide a positive and supportive working environment within one of the most engaged teams in the industry. We recognize that our employees are the cornerstone of our success and offer opportunities for personal and professional growth. In addition, we provide a competitive remuneration package and corporate training.

To apply for this position, please submit your CV in English through our website.

Please note that only shortlisted candidates will be contacted.

Thermo Fisher Scientific is an equal opportunity employer.