Pharmacovigilance Project Specialist

🔥 1 hour ago

🌐 Bulgaria, Romania, +2 more countries – Remote

🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote 🇸🇰 Slovakia – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

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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Premier Research

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 Venture Round on 2016-10

Healthcare • Consulting • Biotechnology

Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.

📋 Description

• Partner with Drug/Device Safety Officers, Safety Project Managers, or senior management to ensure overall pharmacovigilance project delivery through coordination and oversight of cross-functional study teams • Ensure compliance with standard operating procedures and ICH/GCP best practices • Support team communications and documentation by maintaining project contact lists, developing meeting agendas, capturing minutes, and managing action/decision logs • Support development and maintenance of financial tools to track project budgets and out-of-scope services • Generate routine SAE, SUSAR, and AESI report listings for sponsors or internal teams • Support KPI collation and Governance slide deck development • Ensure assigned projects are audit ready and tasks comply with Safety Management Plans, project plans, and SOPs • Manage Trial Master File document collation and indexing • Create and maintain project SOP indices, study team lists, and email distribution lists • Support kick-off meeting slide deck development • Create and maintain project training matrices and document study-specific training completion • Support preparation for sponsor or regulatory agency audits and inspections

🎯 Requirements

• Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred • Experience with Pharmacovigilance preferred • Basic knowledge of ICH/GCP regulations • Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures • Basic knowledge of project management terminology and guidelines • Strong computer skills in MS office suite required • Fluent in English

🏖️ Benefits

• Flexibility and balance to support your life requirements • Skills and opportunities for professional growth and career development