Senior Pharmacovigilance Associate

🔥 13 hours ago

🌐 New Zealand, Romania – Remote

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⏰ Full Time

🟠 Senior

✨ Associate

👻 Ghost score 16%

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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

• 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 activities • Manage SAE/SUSAR activities, 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 • Produce database outputs and reports, including monthly client reporting data • Manage workflow and resources • Support pharmacovigilance processes for PrimeVigilance and 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 a specified country and PRLS for a 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 environment • Growth opportunities • Collaborative and supportive team culture • Global reach and international work environment • Belonging-focused workplace • Opportunity to contribute to patient safety and pharmaceutical treatment outcomes

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