Location: Shanghai, Shanghai, China | Type: Remote | Country: CN**Who We Are**Emerald Clinical Trials is aglobal leaderin clinical research, partnering with over160 biotechcompanies and15 of the world’s top 20pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offeringPhase I-IV and real-world studies. With over25 years of experienceand aworld-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact.Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. Our1000+ employees that span across Asia-Pacific, Europe, and the Americasare embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward. About The RoleThe Senior Drug Safety Specialist is responsible for the implementation and management of safety service operations to ensure all safety services are delivered in line with the applicable guidelines and regulations. The Senior Drug Safety Specialist liaise with other functions and management within Emerald Clinical Trials to ensure quality, compliance, and effective functioning of safety services. ResponsibilitiesSafety Services DevelopmentAssist in budget preparation, proposal review, participate in bid defence meetings, preparation and maintenance of business development and marketing materials for expanding safety services business.Develop SOPs, WIs and ADs for clinical trial and post marketing related regulatory and/or safety reporting activities, in collaboration with Quality Management team representatives and subject matter experts, as applicable.Identify the requirements for the systems, process, documents and ensure they are in place to support the delivery of safety services for preclinical, clinical, and post-marketing safety projects.Contribute to the implementation, centralisation and improvement of processes, procedures, and systems applicable to the safety services.Communicate with sponsor or client for their feedback and demands, ensure high quality delivery to achieve long-term cooperation with clients.Develop and implement standard KPIs, quality and compliance monitoring process for safety services.Assist with the collation and analysis of safety services metrics and delivery of process improvements as requested for areas/countries of responsibility.Project Delivery and ComplianceDevelop project plans, safety management plans, work instructions and other project related documentation as required, and ensure these are kept up to date.Preparation and coordinate submission of safety regulatory documents to the Regulatory Authorities.Liaise with study team, investigators, site staff, medical monitors, safety/regulatory services consultants, and vendors, if applicable.Tracking of project progress, prepare metrics and provide operational updates to all stakeholders.Evaluate resource requirements and workload management for the for the assigned projects.Coordination of project specific revenue and expense processing for the assigned projects.Review of project finance, change requests, resource utilization and coordinate customer invoice process with the Finance team/ Project Managers.Ensure safety reports, project documents, trackers and training records are kept up to date and filed in TMF/project folders.Perform ongoing review of safety files and complete file review checklists.Proactively identify and escalate any project-related issues, including the scope changes.Organise project and divisional meetings, develop agendas and take minutes.Participate in project team meetings, business development meetings and Audit/ inspection.Maintenance of project specific issue logs/ risks, CAPA preparation and implementation.Safety And Pharmacovigilance Services AccountabilitiesAct as a Safety Lead or Safety Reporting Group (SRG) lead for the assigned projects.Act as a National Responsible Person for Pharmacovigilance (NRPP) for the local Pharmacovigilance activities.Processing, evaluating, and reporting of safety events with emphasis on timeliness and quality for drugs, vaccines, and cosmetics, this includes:Case intake, duplicate check, and case registration.Processing of serious and non-serious safety reports as per the internal/project policies and procedures into the safety database.Generate medically relevant safety narrative of safety reports.Medical coding all medical history, events, drugs/ procedures/ indications, and laboratory tests according to the appropriate dictionary (e.g., MedDRA, Company Product Dictionary, WHO-DD).Perform quality review of safety data entered the safety database for completeness and accuracy and provide quality feedback to the case processors.Review and evaluate safety information to determine required action based on and following internal policies and procedures.Generate safety queries and follow-up with sites/reporter regarding outstanding queries.Preparation and submission of periodic safety reports to the applicable parties.About YouEducation and ExperienceA full‑time undergraduate degree or higher in medical and health‑related majors.At least 2 years of relevant drug safety experience.Extensive knowledge and understanding of international regulations and guidelines that relate to clinical trial safety management, post-marketing pharmacovigilance and device vigilance.Extensive experience in Pharmacovigilance Standard Operating Procedures/ Work Instructions development.High level of proficiency at all Pharmacovigilance workflow tasks.Hands on experience in utilising the Argus and/or ArisGlobal safety databases.Proven track record of excellent leadership abilities.Experience in setting up market research standards, systems, processes, and applications used for Pharmacovigilance activities.Thorough knowledge of medical terminology.In-depth knowledge and understanding of Pharmacovigilance guidelines and regulatory reporting requirements.Relevant experience in a clinical research environment.A high degree of customer service and responsiveness.Experience in mentoring and motivating colleagues to accomplish tasks.Previous experience networking with key stakeholders.Collate, track, and distribute safety reports to the Sponsor, Clinical Investigators, Regulatory Authorities, Ethics Committees, and Data Safety Monitoring Boards in line with the project manuals and timelines.Reconciliation of cases between safety database and clinical database according to defined processes, if needed and follow-up on reconciliation of discrepancies.Conduct literature search and review on local/international scientific and medical literatures to identify Individual Case Safety Reports (ICSRs) and other safety relevant information in line with the project manuals and timelines.Closure and deletion of case reports in the safety database.Perform Signal Management, Risk Management and Medical Information Management activities.Contribute to Aggregate Report preparation for the assigned projects.Medical Device Vigilance Services AccountabilitiesAct as a subject matter expert in technical, regulatory, and quality issues related to medical devices.Ensure processing and reporting of device vigilance reports, including but not limited to, incident reports, potential safety incident criteria or new findings, device deficiencies and adverse device events/ effects or adverse reaction data from clinical and post-marketing sources as per the applicable regulations/ guidelines.Perform medical device vigilance reporting to the Competent Authorities as per the local regulations in a timely manner.Preparation, review and maintenance of medical device project plans and risk management plans.Preparation, review, and analysis of safety data for trend reports and identification of potential corrective or preventive actions.Monitoring, analysing, and applying trending methodologies to the vigilance data submitted to Competent Authorities.Preparation, review and distribution of medical device analysis reports and field safety notices.Perform signal detection activities for medical device vigilance and present signal detection results on periodic basis to evaluate new/emerging safety issues/trends.Perform medical device literature search, reviews, and processing of literature safety reports.Preparation of clinical evaluation or periodic safety reports for medical devices.Create and conduct medical device and risk management trainings.Perform verification of medical device reports, including support of data compiled for metrics, risk evaluations and various other activities.Regulatory IntelligenceAct as an information point for safety regulatory related enquiries both internally and externally.Conduct ongoing surveillance of new and updated international regulations/ guidelines and assess the impact on safety management processes in consultation with the regulatory authorities as required.Ensure up to date regulatory information is available across Emerald Clinical.Review and maintain the SOPs, WIs, process documents, training materials, project safety plans, manuals, and other project related documentation to consistently meet the regulatory requirements.Training, Quality and ComplianceComplete mandatory training for this role within specified timelinesAttend mandatory training sessions required for this roleIdentify resources and training to support learning and development within this roleComply with all applicable regulations, guidelines, SOPs and project-specific requirementsComply with all designated systems relevant to this roleEnsure own quality control of all relevant processes and activities performedReport and escalate identified risks and issues in areas of responsibility according to Emerald Clinical and/or project requirementsCustomer Focus and TeamworkAttend and actively participate in Emerald Clinical meetings and other internal meetings and activities as requiredProvide input to systems, tools and processes to support continuous improvementShare knowledge with others, to facilitate learning and development across the organisationWork Health and SafetyComply with Work Health & Safety (WH&S) legislation and operate in accordance with established organisational WH&S practice and proceduresPromote and contribute to a safe, secure environment for staff and visitorsCompetenciesExcellent communication skills and interpersonal skills and the ability to work well and flexibly (i.e., autonomously, in small teams and with a wide range of varying stakeholders).Technological proficiency including Microsoft Office packagesAbility to see the big picture, yet still focus on detail and quality of workAbility to be flexible and adaptable in the face of changing organisational priorities**Why Join Us?**At our core,Emerald Clinical Trialsis committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s What Makes Us Stand OutPurpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.**What We Offer**We understand that great work happens when people feel valued and supported. That’s why we provide:Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.Interested?Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates.
7 days ago