Qualified Person Responsible for Pharmacovigilance (QPPV), EU - UK

Job not on LinkedIn

🔥 13 minutes ago

🌐 United Kingdom, Spain – Remote

infoinfo

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on ERGOMED's careers page, not through a job board

First seen by Remote Rocketship 13 minutes ago

Logo of ERGOMED

ERGOMED

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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

• Establish and maintain a system ensuring suspected adverse reaction information is collected, collated, and accessible within the Community • Ensure requests from competent authorities for additional medicinal-product benefit-risk information are answered fully and promptly • Provide competent authorities with other information relevant to medicinal-product benefit-risk evaluation, including planned post-authorisation safety studies • Remain continuously available to competent authorities in Member States, the Agency, and the marketing authorisation holder • Ensure adequate back-up procedures are in place • Oversee safety aspects of the company’s medicinal products • Maintain an overview of medicinal-product safety profiles and emerging safety concerns • Monitor marketing-authorisation safety conditions, obligations, and other safety-related commitments • Review relevant findings from company-conducted studies and programmes

🎯 Requirements

• Life-science education background • Medicine (human or veterinary) or Pharmacy preferred • Solid knowledge of PV system operations and function • Strong knowledge of Global Regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance activities in post-marketing • Strong operational and managerial skills, demonstrated by leading previous projects or functions • Strong experience in a PV role • Profound experience as QPPV • Strong oral and written English communication skills

🏖️ 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 • English as the company language • Diversity, equity, and inclusion-focused equal opportunities workplace • Human-centric environment • Employee experience, well-being and mental health focus • Healthy work-life balance

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