🧠 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!
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