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Senior Medical Writer I (Line Management Experience Required)

0-2 years
Not Disclosed
10 Oct. 2, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

🧠 Job Title: Senior Medical Writer I (Line Management Experience Required)

🏢 Company: PrimeVigilance (part of Ergomed Group)
📍 Location: Bucharest, Romania
🕒 Employment Type: Full-time
📂 Department: Medical Writing


🌍 About PrimeVigilance

PrimeVigilance, established in 2008, is a specialized mid-size pharmacovigilance service provider with global operations across Europe, North America, and Asia.

  • Services: Medical Information, Pharmacovigilance, Regulatory Affairs, Quality Assurance

  • Client Base: Small to large pharmaceutical and biotechnology partners

  • Therapy Areas: All, including medical devices

  • Culture: Focused on staff training, development, well-being, and work-life balance to ensure high-quality client service


🧾 Job Description

The Senior Medical Writer I role provides an opportunity to develop your career in drug safety within an international team of experienced aggregate report writers. You will contribute to departmental growth and mentor junior writers.


🔹 Key Responsibilities

  • Independently author, edit, and review various regulatory/clinical documents, including:

    • Aggregate reports (DSURs, PSURs, RMPs, ACOs)

    • Risk management plans

    • Other documents needed throughout a product’s life cycle

  • Ensure quality, content, and compliance with internal and external standards

  • Participate in training, development, and maintenance of medical writing quality system documents, including templates and standardized formats

  • Support all pharmacovigilance operations related to medical writing

  • Continuously self-educate on medical writing and regulatory requirements

  • Manage a team of junior medical writers


🎓 Qualifications

  • Life Science degree (PhD or Master’s preferred)

  • Extensive experience in full PV aggregate report writing (DSURs, PSURs, RMPs, ACOs)

  • Experience in pharmacovigilance and working in a CRO/service provider environment preferred

  • Line Management experience required

  • Excellent communication skills in English (additional languages desirable)


🌟 Why PrimeVigilance

  • Diversity & Inclusion: Equal opportunity, human-centric workplace

  • Career Development: Internal training and growth opportunities

  • Global Collaboration: Work with colleagues worldwide (English as company language)

  • Supportive Culture: Friendly, collaborative, value-driven environment

Core Values:

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships

🔹 Join PrimeVigilance to contribute to patient safety and make a positive impact on global health!