Senior PV Associate

Job not on LinkedIn

🔥 3 hours ago

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

✨ Associate

👻 Ghost score 16%

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.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

• 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 timeframe • Process Individual Case Safety Reports from all sources in compliance with applicable regulations, company procedures, client requirements and timelines • Perform ICSR follow-up activities • Manage SAEs/SUSARs, including unblinding, clinical trial reconciliation and protocol review • Review Safety Management Plans • 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 • Prepare database outputs and reports, including monthly client reporting data • Support workflow and resource management • Support PV 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 assigned • Act as PRLS for the designated language when assigned

🎯 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 • Advanced English, spoken and written • Advanced literacy in 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 • English as the company language • Equal opportunities workplace • Human-centric environment • Focus on employee experience, well-being and mental health • Healthy work-life balance

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