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Medical Writer

3+ years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: MSc./M. Pharm/PhD 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 - Pharmacovigilance

Location: PrimeVigilance (Remote or specific regions based on office locations)
Team Locations: North America, Europe, and Asia


About PrimeVigilance

PrimeVigilance is a leading provider of pharmacovigilance and medical writing services, helping pharmaceutical and biotechnology companies to ensure the safety and efficacy of their products. The company supports its clients through comprehensive safety management, regulatory services, and medical writing solutions across the product lifecycle.


Key Accountabilities

As a Medical Writer in Pharmacovigilance, you will:

  • Author Medical Writing Tasks:
    • Prepare high-quality medical documents including aggregate reports, Risk Management Plans (RMPs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and other critical documents throughout the product lifecycle.
  • Document Quality Control:
    • Review and ensure the quality and content accuracy of documents written by peers in the Medical Writing team.
  • Self-Development:
    • Continuously educate yourself on all aspects of medical writing, particularly in the pharmacovigilance area.
  • Training and Quality System Maintenance:
    • Actively participate in training programs, and help maintain and develop quality system documents related to medical writing.
  • Support PV Operations:
    • Provide support in all pharmacovigilance operations associated with medical writing tasks.

Qualifications

Education:

  • PhD or MSc in Life Sciences or Healthcare fields such as pharmacy, biology, chemistry, or veterinary medicine.

Experience:

  • Previous experience in drug safety medical writing, including preparing PBRERs, DSURs, RMPs, and other pharmacovigilance-related documents.

Skills:

  • Time Management & Organization: Ability to manage multiple tasks, prioritize effectively, and maintain attention to detail.
  • Communication: Strong written and verbal communication skills, including the ability to present complex medical information clearly and concisely.
  • MS Office: Advanced proficiency in MS Office applications (Word, Excel, PowerPoint).
  • Fluency in English: Strong command of the English language, both written and spoken.

Additional Information

This position offers the opportunity to further develop your career in Pharmacovigilance Medical Writing, with exposure to a global team across North America, Europe, and Asia. You will have a chance to make a significant impact in ensuring the safety and compliance of medical products.


PrimeVigilance is committed to equal opportunity employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected status.