PV Associate

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ERGOMED

WebsiteLinkedInAll Job Openings

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

• Provide support to other activities undertaken by the project team on behalf of the client and the company • Perform ICSR management activities within agreed scope and timelines • Process Individual Case Safety Reports from all sources in compliance with applicable regulations, PrimeVigilance procedures, client requirements and timelines • Perform ICSR follow-up activities • Manage SAEs and SUSARs, including unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review • Perform clinical and partner reconciliation • Handle personal data protection activities • Handle Product Quality Complaints and interact with Quality Assurance • Interact with Medical Information • Perform MedDRA and WHO coding • Support pharmacovigilance processes related to ICSR management for PrimeVigilance and clients • Support the RA & PV Network Department as needed • Act as LCPPV for the specified country when agreed with the line manager • Act as PRLS for the designated language when agreed with the line manager

🎯 Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • 0-1 year of experience in pharmacovigilance, desirable but not required • Organization skills, including attention to detail and multitasking • Management skills, including time and issue management • Advanced spoken and written English • Advanced literacy in MS Office

🏖️ Benefits

• Remote work option • Flexible work environment • Growth and professional development opportunities • Collaborative and supportive team culture • Belonging and inclusive workplace • Opportunity to contribute to patient safety and pharmaceutical treatment • Global reach and collaboration across Europe, North America, South America, Asia and Australia