Drug Safety Officer

🔥 3 minutes ago

🌐 Portugal, Poland, +3 more countries – Remote

🇵🇹 Portugal – Remote 🇵🇱 Poland – Remote 🇪🇸 Spain – Remote 🇬🇧 United Kingdom – Remote 🇸🇪 Sweden – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Handle serious adverse events in clinical trials and spontaneous market reports • Collect, assess, and enter safety cases into the safety database • Review and approve processed cases and perform AE/SAE reconciliation • Code adverse events, medical history, and concomitant medication using MedDRA and WHO-Drug Dictionary • Perform quality control and approve safety coding • Review and write safety sections for clinical study protocols • Review clinical trial reports and investigator brochures from a safety perspective • Write safety sections for PSUR/PBRER, DSURs, IND, NDA, and other safety documents • Conduct literature searches • Perform electronic reporting to EudraVigilance • Contribute to post-approval surveillance plans, instructions, and SOPs • Update safety-handling templates for studies and projects • Act as Project Lead for safety-only projects when required • Participate in relevant meetings and communicate information to department and study team members • Provide internal support to relevant departments • Participate in process improvement projects • Contribute to developing routines that enhance work at TFS • Validate department-specific computer applications for drug safety requirements • Stay updated on laws, directives, and guidelines related to safety reporting and pharmacovigilance • Educate and supervise new Drug Safety personnel • Participate in marketing activities

🎯 Requirements

• 5 years of relevant experience • Ability to work in a fast-paced environment with changing priorities • Understanding of medical terminology and science associated with assigned drugs and therapeutic areas • Understanding of Good Clinical Practice regulations, ICH guidelines, pharmacovigilance legislation, and internal SOPs • Ability to work independently and in a team matrix organization with little or no supervision • Excellent written and verbal communication skills • Proficiency using typical word processing software • Spreadsheet skills desirable • Presentation software knowledge a plus

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Equal opportunity employment for candidates based in Spain, including people with disabilities