Senior Drug Safety Specialist

Job not on LinkedIn

🔥 9 minutes ago

🇸🇬 Singapore – Remote

⏰ Full Time

🟠 Senior

✨ Safety Specialist

👻 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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Emerald Clinical

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Emerald Clinical is a leading global clinical research organization (CRO) founded in the Asia‑Pacific region that provides end‑to‑end clinical trial services to biopharmaceutical, medical device, and diagnostic companies. With about 25 years of experience and a team of 800+ operating across 40+ locations worldwide, Emerald Clinical manages trials across all phases including registration and post‑marketing studies, and offers clinical operations, project management, and trial staffing support. The company emphasizes scientific expertise, operational excellence, and global reach to support drug and device development.

📋 Description

• Implement and manage safety service operations in line with applicable guidelines and regulations • Liaise with internal functions and management to ensure quality, compliance, and effective safety service delivery • Assist with budgets, proposal reviews, bid defence meetings, and business development materials • Develop SOPs, Work Instructions, activity descriptions, process improvements, KPIs, and quality/compliance monitoring processes • Identify and implement systems, processes, and documentation supporting preclinical, clinical, and post-marketing safety projects • Communicate with sponsors and clients to gather feedback and ensure high-quality delivery • Develop project plans, safety management plans, work instructions, and project documentation • Prepare and coordinate safety regulatory submissions • Liaise with study teams, investigators, site staff, medical monitors, consultants, and vendors • Track project progress, prepare metrics, and provide operational updates • Manage resources, workload, project finances, expenses, change requests, invoicing, and utilization • Maintain safety reports, project documents, trackers, training records, issue logs, risks, and CAPA documentation • Act as Safety Lead, Safety Reporting Group lead, or National Responsible Person for Pharmacovigilance • Process, evaluate, code, quality-review, and report safety events for drugs, vaccines, cosmetics, and medical devices • Generate safety narratives, queries, periodic safety reports, aggregate reports, trend reports, field safety notices, and clinical evaluation reports • Reconcile safety and clinical databases and follow up on discrepancies • Conduct scientific and medical literature searches to identify safety reports and relevant information • Perform signal management, risk management, medical information management, and device vigilance activities • Conduct regulatory intelligence surveillance and assess impacts on safety processes • Maintain regulatory information, SOPs, training materials, project safety plans, manuals, and related documentation • Complete mandatory training and support learning and development • Participate in meetings, audits, inspections, and continuous improvement activities • Share knowledge across the organisation and promote workplace health and safety

🎯 Requirements

• A full-time undergraduate degree or higher in medical and health-related majors • At least 2 years of relevant drug safety experience • Extensive knowledge of international regulations and guidelines related to clinical trial safety management, post-marketing pharmacovigilance, and device vigilance • Extensive experience developing Pharmacovigilance Standard Operating Procedures and Work Instructions • High proficiency in Pharmacovigilance workflow tasks • Hands-on experience using Argus and/or ArisGlobal safety databases • Proven leadership abilities • Experience setting up market research standards, systems, processes, and applications for Pharmacovigilance activities • Thorough knowledge of medical terminology • In-depth knowledge of Pharmacovigilance guidelines and regulatory reporting requirements • Relevant experience in a clinical research environment • High degree of customer service and responsiveness • Experience mentoring and motivating colleagues • Previous experience networking with key stakeholders • Knowledge of medical device vigilance, including applicable technical, regulatory, and quality requirements • Excellent communication and interpersonal skills • Ability to work autonomously, in small teams, and with varied stakeholders • Technological proficiency, including Microsoft Office packages • Ability to balance strategic perspective with attention to detail and quality • Flexibility and adaptability to changing organisational priorities • Compliance with applicable regulations, guidelines, SOPs, project requirements, and designated systems • Ability to comply with Work Health & Safety legislation and organisational procedures

🏖️ Benefits

• Competitive compensation with a tailored salary and benefits package • Hybrid or remote working arrangements, depending on location and role • Learning opportunities and access to a global network of scientific leaders • Employee wellbeing programs and initiatives supporting work-life balance, health, and team connection • Global engagement surveys • Recognition programs • Team-building events • Exposure to diverse international projects and clients