Senior Pharmacovigilance Associate

🕒 July 15

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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

• Performing activities in the scope of ICSR management unit within agreed extent and timeframe: Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines • Performing ICSR follow up SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) • Reconciliation (clinical, partners) • Personal data protection • Product Quality Complaint handling and interaction with Quality Assurance • Medical Information interaction • MedDRA and WHO coding • Database Outputs and Reports (including data for monthly reporting to clients) • Workflow & resource management • Support of PV processes related to the ICSR management within PrimeVigilance and also to clients

🎯 Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • Minimum 1 year of work experience in pharmacovigilance • Organization skills, including attention to detail and multitasking • Management skills, including time and issue management • English - advanced (spoken, written) • Advanced literacy (MS Office)

🏖️ Benefits

• Flexible work arrangements • Professional development opportunities