Senior Pharmacovigilance Associate

🔥 20 hours ago

🌐 New Zealand, Romania – Remote

🇳🇿 New Zealand – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

✨ Associate

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific requirements, and timelines • Perform ICSR follow-up, including SAE/SUSAR management, 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 • Produce database outputs and reports, including data for monthly client reporting • Manage workflow and resources • Support pharmacovigilance processes within PrimeVigilance and for clients • Perform tasks assigned to more junior positions as appropriate for a senior colleague • Support the RA & PV Network Department as needed • Act as LCPPV for the specified country as agreed with the line manager • Take on the PRLS role for the designated language as agreed with the line manager

🎯 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

• Remote work option • Flexible work culture • Growth opportunities • Collaborative and supportive team environment • Global work environment • Belonging and inclusive culture • Opportunity to contribute to patient safety • Work with experts in clinical research, pharmacovigilance, and quality consulting