Clinical Trial Drug Safety Specialist I

Job not on LinkedIn

🔥 2 hours ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Specialist

👻 Ghost score 10%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Perform pharmacovigilance (PV) and medical device vigilance (MDV) activities for clients in compliance with company SOPs, working practices, and regulatory guidelines • Train on study-related materials for processing Individual Case Safety Reports (ICSRs), including study protocols and Safety Management Plans • Receive, track, triage, and book serious adverse event, device incident, and pregnancy reports into the Argus safety database • Review, assess, and process cases from ongoing drug or device clinical trials • Review report forms and supplementary reports; redact personal identifying information as necessary • Enter relevant case details into Argus • Write patient narratives using demographic, medical history, concomitant medication, and adverse event data • Generate and send queries for critical or missing information • File and save case documentation, including uploading source files • Perform quality control reviews of safety database data entered by other PV personnel • Perform user acceptance testing of safety database builds • Participate in designing serious adverse event report forms • Review study-specific Safety Management Plans • Assist with reconciliation of safety data between clinical and safety databases • Provide rotating weekend/holiday coverage for case processing and expedited reporting • Ensure compliance with applicable regulations and safety case processing/reporting timelines • Keep current with pharmacovigilance and medical device vigilance guidance and regulations • Plan and manage deliverables and timelines according to clinical trial project team requirements

🎯 Requirements

• At least a Bachelor degree in Clinical or Medical or Life Sciences • Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards is an asset • Prior experience with pharmacovigilance processes is an asset • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines (preferred) • Strong verbal and written communication skills with the ability to understand and summarize medical terminology (preferred) • Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data • Detail-oriented, customer- and quality-focused • Excellent interpersonal and teamwork skills • Computing skills in MS Office applications

🏖️ Benefits

• Remote work arrangement • Rotating weekend/holiday coverage (job-related scheduling arrangement) • Equal opportunity and accommodations for candidates with disabilities