Senior Pharmacovigilance Associate

Job not on LinkedIn

🔥 5 hours ago

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

✨ Associate

👻 Ghost score 17%

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 requirements, and timelines • Perform ICSR follow-up activities • Manage SAEs/SUSARs, 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 • Prepare 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 the specified country and PRLS 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 • Advanced spoken and written English • Advanced literacy in MS Office

🏖️ Benefits

• Remote work option • Flexible work environment • Growth opportunities • Supportive and collaborative team culture • Belonging and inclusive workplace • Opportunity to work on global pharmacovigilance projects • Opportunity to help protect patients through meaningful work