🧠 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!
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