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Medical Writer

0-2 years
Not Disclosed
10 April 29, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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:
Medical Writer

Company:
PrimeVigilance

Location:
Global – North America, Europe, or Asia (remote or regional office-based depending on location)

Function:
Pharmacovigilance / Medical Writing

Work Pattern:
Not specified (assumed flexible/remote based on global team)


Job Description:
The Medical Writer at PrimeVigilance will be responsible for authoring and reviewing safety-related regulatory documents such as aggregate reports, Risk Management Plans (RMPs), and Periodic Benefit-Risk Evaluation Reports (PBRERs). The role includes document quality assurance, cross-functional collaboration with pharmacovigilance teams, and contribution to the continuous improvement of quality systems.


Key Accountabilities:

  • Author aggregate safety reports (e.g., DSURs, PBRERs), RMPs, and other safety documents throughout the product lifecycle

  • Perform quality control review of documents created by other Medical Writers

  • Stay current with medical writing best practices and pharmacovigilance requirements

  • Contribute to training programs and maintenance of standard operating procedures (SOPs)

  • Support other PV-related operations involving medical documentation


Qualifications:

  • PhD or MSc in Life Sciences or Healthcare (e.g., Pharmacy, Biology, Chemistry, Veterinary Medicine)

  • Previous experience in pharmacovigilance medical writing (PBRERs, DSURs, RMPs)

  • Excellent time management, organization, and multitasking abilities

  • Strong communication and presentation skills

  • Proficient in MS Office tools

  • Fluent in English