Senior PV Associate / Junior PV Officer

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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

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. • As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. • Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations). • Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.). • Mentoring and training of new and more junior employees within the department, including procedure optimization and development.

🎯 Requirements

• Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing • Demonstrated case processing experience • ARGUS experience preferred • Time and issue management, delegation, organization and multitasking skills with good attention to detail • Strong interpersonal and communication skills • Advanced English skills, both verbal and written, at least C1

🏖️ 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