PV Assistant

Job not on LinkedIn

🔥 4 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Receiving and returning safety messages and acknowledge receipt, tracking and filing of Individual Case Safety Reports (ICSRs) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines • Perform other miscellaneous administrative tasks, as applicable • Performing activities in the scope of ICSR management unit within agreed extent and timeframe • Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

🎯 Requirements

• High school or university graduate • Experience desirable, but not required in administrative position • Good communication skills • Experience with administrative work • English - advanced (spoken, written) • Advanced literacy (MS Office)

🏖️ Benefits

• Training and career development opportunities internally • Strong emphasis on personal and professional growth • Friendly, supportive working environment • Opportunity to work with colleagues based all over the world, with English as the company language