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Medical Writer

2+ years
Not Disclosed
10 Nov. 8, 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

About PrimeVigilance

PrimeVigilance, part of Labcorp Drug Development, is a leading provider of pharmacovigilance and medical writing services. Our Medical Writing team plays a critical role in ensuring the accuracy, clarity, and regulatory compliance of all documents related to the lifecycle of pharmaceutical products. Join a dynamic global team and advance your career in Pharmacovigilance Medical Writing with PrimeVigilance.


Job Overview

The Medical Writer will be responsible for authoring and reviewing key pharmacovigilance documents, such as aggregate reports, Risk Management Plans (RMPs), and other documents needed throughout the product lifecycle. The role requires a strong understanding of drug safety writing, an eye for detail, and a commitment to quality.


Key Accountabilities

  • Medical Writing & Document Preparation:
    Author and review pharmacovigilance documents, including aggregate reports, PBRERs, DSURs, RMPs, and other safety-related reports, ensuring accuracy, clarity, and compliance with regulatory standards.

  • Quality Control & Review:
    Take responsibility for the quality and content of documents, ensuring that written materials meet the required standards. Conduct quality control reviews of documents prepared by Medical Writing peers.

  • Ongoing Education:
    Continuously update knowledge of pharmacovigilance regulations and medical writing best practices to stay at the forefront of industry standards.

  • Training & Development:
    Actively participate in internal training sessions and contribute to the development of quality system documents related to medical writing.

  • Support PV Operations:
    Provide support across pharmacovigilance operations, contributing to the overall functioning and success of the Medical Writing team.


Qualifications

  • Education:
    PhD or MSc in Life Sciences or Healthcare (e.g., pharmacy, biology, chemistry, veterinary medicine).

  • Experience:
    Previous experience in drug safety medical writing, including preparation of PBRERs, DSURs, and RMPs.

  • Technical Skills:
    Advanced proficiency in MS Office (Word, Excel, PowerPoint).

  • Skills:

    • Strong time management, organization, and multitasking abilities.
    • Excellent attention to detail and the ability to produce high-quality work under tight deadlines.
    • Strong communication and presentation skills.
    • Fluency in English, both written and verbal.

Why PrimeVigilance?

PrimeVigilance offers a collaborative and innovative environment where you can further your career in pharmacovigilance medical writing. Join a growing, global team of professionals dedicated to improving drug safety and regulatory compliance.