Safety Physician

🕒 July 9

🌐 Serbia, Bulgaria – Remote

🇷🇸 Serbia – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 31%

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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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide medical review and assessment for ICSRs, with targeted focus on high-interest/priority cases and submission readiness • Lead supplemental medical review of key cases, ensuring clinical interpretation, seriousness/expectedness considerations, and consistent documentation • Provide targeted offline quality control for medical review and/or case processing, including root cause analysis and improvement actions • Lead targeted follow-up strategies and engage medical affairs, healthcare professionals, and vendors for priority or complex cases • Oversee ICSR coding standards, including MedDRA and WHO Drug conventions • Perform or coordinate coding standards reviews, trend findings, identify training needs, and update guidance • Develop, maintain, and deliver PV standards, conventions, and training materials • Provide medical expertise and support to Benefit-Risk activities and safety strategy • Support Literature QC activities affecting medical review and case processing • Act as an SME during internal audits, vendor audits, and regulatory inspections • Manage and oversee the medical review operating model, including prioritization, timeline adherence, and risk escalation • Serve as point of contact for medical review requirements across GPV Reporting Operations, Patient Benefit Risk, Medical Safety, PV Quality, and cross-functional stakeholders • Develop, revise, and maintain a scalable medical review process for clinical-trial and post-marketing case processing • Contribute to external vendor/partner governance, performance oversight, and CAPA • Partner with PV Operations leadership on operational strategy, multi-year roadmaps, and automation initiatives • Monitor medical review operational and quality metrics and drive improvements

🎯 Requirements

• Ph.D. or Medical Degree (M.D.) • Experience in the pharmaceutical industry or a clinically oriented discipline • Extensive knowledge of ICSR management, reporting requirements, literature surveillance monitoring, safety data management systems, and aggregate safety data • Minimum 2–3 years of experience in pharmacovigilance/drug safety • Demonstrated medical review of ICSRs • Understanding of pharmacovigilance regulations in clinical and post-marketing settings • Working knowledge of MedDRA and WHO Drug coding principles and their application to ICSR quality and reporting • Experience in operational oversight and/or leading cross-functional processes, including vendor oversight and performance monitoring, desired • Strong communication skills and ability to convey complex technical information to diverse audiences • Self-motivated, proactive problem-solving mindset and ability to drive continuous improvements • Ability to lead, drive, and execute complex projects independently • Strong analytical and risk assessment skills • Ability to anticipate challenges and implement effective solutions

🏖️ Benefits

• Resources needed to achieve individual career goals • Diverse experiences, backgrounds and perspectives valued • Reasonable accommodation for individuals with disabilities during application/interview and employment • Equal opportunity employment