Pharmacovigilance Physician

Job not on LinkedIn

🔥 21 minutes ago

🇪🇺 Europe – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 12%

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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Evestia Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1996

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Evestia Clinical is a global specialist Contract Research Organization (CRO) that provides customized clinical development services to biotech innovators. Formed through the acquisition of EMAS Pharma by Kester Capital and a subsequent strategic merger with Atlantic Research Group (ARG), Evestia Clinical operates from headquarters in Letchworth, UK and Charlottesville, Virginia, USA. The combined team of over 150 professionals delivers tailored solutions across the full drug development lifecycle (Phase 1–3 and beyond), with particular expertise in oncology, neurology, rare diseases, immunology, and inflammation. The company emphasizes global trial infrastructure, regulatory support, integrated data and biostatistics platforms, and personalized, agile clinical research services for biotech clients.

📋 Description

• Perform medical review of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing projects • Assess seriousness, causality, and expectedness/labeledness of reported events • Review MedDRA and WHO Drug coding for adverse events and concomitant medications • Author medical assessments, company comments, medical summaries, and safety-related queries • Review cumulative analyses of similar adverse events, including Analysis of Similar Events (AOSE) • Provide medical support, guidance, mentoring, and training to the pharmacovigilance team • Review scientific literature to identify potential safety signals or valid ICSRs • Provide medical advice, data interpretation, and strategic guidance to internal departments, clients, and external partners • Support responses to regulatory authority requests, inspections, sponsor audits, and safety inquiries • Review and approve periodic safety reports, including PBRERs, PSURs, and DSURs • Participate in signal detection, signal validation, and signal assessment activities • Contribute to benefit-risk assessments, Risk Management Plans, and Safety Management Plans • Participate in or present safety data at Safety Management Committees, Data Safety Monitoring Boards, and sponsor safety governance meetings • Provide occasional clinical medical monitoring support during peak workloads or team absences • Assist investigators with protocol eligibility, safety concerns, and data management queries • Review clinical trial data listings, laboratory reports, and subject profiles for medical accuracy and safety concerns • Ensure pharmacovigilance and medical monitoring activities comply with ICH-GVP, ICH-GCP, FDA, EMA, SOPs, and client requirements

🎯 Requirements

• Primary medical degree (e.g., MD, MBBS, MBChB, DO or equivalent) from an accredited medical school • Active or previously held medical license/registration • Minimum of 2 years of experience as a physician in the pharmaceutical industry or a CRO, primarily focused on Pharmacovigilance and Drug Safety • Hands-on experience performing medical review of ICSRs • Working knowledge of global drug safety and pharmacovigilance regulations, including ICH, FDA, and EMA • Strong scientific, clinical, and analytical knowledge • Ability to read, analyze, and interpret scientific and clinical data • Excellent oral and written communication skills • Proficiency navigating clinical and pharmacovigilance safety databases • Ability to exercise independent medical judgment and make timely, evidence-based decisions • Excellent cross-functional collaboration and communication skills • Strong knowledge of MedDRA and WHO Drug coding dictionaries

🏖️ Benefits

• Collaborative and flexible working environment • Opportunities for professional growth • Supportive culture focused on wellbeing, personal development, and work-life balance • Opportunity to influence patient safety on a global scale • Meaningful work benefiting patients around the world