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Medical Reviewer I

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: Medical Reviewer I

🏢 Company: PrimeVigilance (part of Ergomed Group)
📍 Location: Remote
🕒 Employment Type: Full-time
📂 Department: PV Medical Group


🌍 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

🔹 Client-Facing Responsibilities

  • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports from clinical trials, including:

    • Medical/causality assessment

    • Coding, assessment of seriousness, listedness/expectedness, and company causality

    • Writing company comments, follow-up questions, and analyzing similar events

    • Completing all required supporting documentation (trackers)

  • Review literature screening search strategies

  • Assess articles for ICSRs/SAEs or other safety-related findings related to medicinal products

  • Review database outputs

  • Provide input in Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)

  • Participate in signal detection activities, including:

    • Attending meetings

    • Writing signal detection reports

    • Proposing actions when possible signals are identified

🔹 Company-Facing Responsibilities

  • Write pharmacovigilance (PV) procedures

  • Mentor less experienced physicians


🎓 Qualifications

  • Medically qualified physician with demonstrated experience in pharmacovigilance

  • Experience in aggregate reports and signal detection is desirable

  • Excellent interpersonal, communication, and presentation skills

  • Strong planning, organization, and multitasking abilities

  • Ability to work effectively across cultures and functions, valuing teamwork


🧰 Key Skills

  • Medical and pharmacovigilance expertise

  • Analytical and assessment skills for ICSRs/SAEs

  • Literature review and safety signal identification

  • Mentorship and team collaboration

  • Ability to handle multiple tasks and prioritize efficiently


🌟 Why PrimeVigilance

  • Diversity & Inclusion: Equal opportunities and human-centric workplace

  • Career Development: Internal training and growth opportunities

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

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

Core Values:

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships

🔹 Join PrimeVigilance to make a positive impact on patient lives!