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Medical Writer

0-2 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: PhD/M.Sc 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

Medical Writer

PrimeVigilance | Full-time | Pharmacovigilance Medical Writing

PrimeVigilance is seeking a Medical Writer to join our global Medical Writing team in North America, Europe, or Asia. This role offers an opportunity to advance your career in Pharmacovigilance Medical Writing while contributing to high-quality safety reports and regulatory documents throughout the product life cycle.

Key Responsibilities

  • Author key pharmacovigilance documents, including aggregate reports, Risk Management Plans (RMPs), and other regulatory documents.
  • Ensure high-quality content and conduct quality control reviews of documents prepared by peers.
  • Stay updated with industry regulations and best practices through continuous self-education.
  • Actively participate in trainings and contribute to the development of quality system documents.
  • Support pharmacovigilance operations related to medical writing.

Qualifications & Skills

  • PhD or MSc in Life Sciences or Healthcare (Pharmacy, Biology, Chemistry, Veterinary Medicine).
  • Previous experience in pharmacovigilance medical writing, including PBRERs, DSURs, and RMPs.
  • Strong time management, organizational, and multitasking skills with attention to detail.
  • Excellent communication and presentation skills.
  • Proficiency in MS Office.
  • Fluency in English (written and spoken).

📍 Location: Remote or Hybrid (North America, Europe, or Asia)
Start Date: ASAP