Senior PV Associate

Job not on LinkedIn

🔥 18 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

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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 activities within the ICSR management unit within agreed scope and timeframe • Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client requirements and timelines • Perform ICSR follow-up, SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review and Safety Management Plan review • Perform clinical and partner reconciliation • Handle personal data protection and Product Quality Complaints • Interact with Quality Assurance and Medical Information teams • Perform MedDRA and WHO coding • Produce database outputs and reports, including data for monthly client reporting • Support workflow and resource management • Support pharmacovigilance processes for PrimeVigilance and clients • 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

• 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 • Equal opportunities workplace • Human-centric environment • Support for employee experience, well-being and mental health • Healthy work-life balance

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