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Thepharmadaily

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8 Thepharmadaily Jobs

Safety Writer II

Thepharmadaily LLP

2-5 years

Remote

1 vacancy

Safety Writer II

Thepharmadaily

posted 5mon ago

Job Role Insights

Key skills for the job

Medical Coding Customer Service Pharmacovigilance Clinical Research Medical Billing Medical Writing

+ 3 more

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

About Thermo Fisher Scientific Inc.

Thermo Fisher Scientific Inc. is a global leader in the life sciences sector, delivering top-notch 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 exciting opportunities for experienced Safety Writers to work on diverse projects across a wide array of therapeutic areas.

Position Overview

As a Safety Writer at Thermo Fisher Scientific, you will play a vital role in delivering high-quality scientific and medical writing services. Youll be an integral part of project teams, providing exceptional customer service and collaborating with clients to ensure successful project execution. Your key responsibilities will include:

Analyzing, interpreting, and presenting complex data effectively.
Writing clear and concise reports and documents.
Managing multiple reports simultaneously while prioritizing tasks to meet strict deadlines.
Facilitating meetings and overseeing the review and comment resolution stages of document preparation.
Interacting directly with clients to provide outstanding customer service.

Qualifications

To qualify for this position, you must have:

A Bachelor s or higher degree in a scientific field.
Excellent written and verbal communication skills in English.
Advanced proficiency in Microsoft Office applications.
Experience in task-based project management and client interaction.
A strong understanding of aggregate safety report writing guidelines, as well as clinical trial 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 at least two 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)

Employment Type: Full Time, Permanent

Functional Areas: Other

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