台灣雙健維康生技顧問有限公司

Pharmacovigilance (PV) Specialist is responsible for the following tasks: • Review of AEs/SAEs from clinical trials; issue and address queries if necessary. • Perform medical coding for adverse events and concomitant medication. • Be the representative and point of contact for safety receiving from clinical sites and reporting to the health authority. • Author SAE narrative and individual case safety reports (ICSR). • Participate in the development of safety-related data collection forms for clinical studies. • Develop and review safety management plans. • Participates in the review of the safety-related sections in the clinical trial documents. • Develop and maintain the safety database and management system. • Perform data analysis to evaluate safety signals and write up analysis results. • Author aggregate reports (PBRERs, PSURs, DSURs, etc.) according to the agreed process and timelines as needed. • Assist with database reconciliations and quality checks. • Maintain current knowledge of adverse event reporting obligations to comply with new or updated regulations.

- Contribute to site initiation, monitoring, close-out and tracking of clinical trial documentation and follow-through at sites on assigned clinical projects in collaboration with Project Managers and/or Assigned Personnel. - Responsible for reviewing study site progress, maintain metrics on enrollment at site level milestones. - Perform study monitoring activities including but not limited to source document verification, data review and compliance, data query generation and resolution, and review of regulatory binder and deliverables. - Obtain and maintain essential documentation in compliance with ICH-GCP, procedural documents and local regulations both in the office and at site. - Prepare study monitoring reports and finalize the report within specified timeline. - Proactively identify study-related issues and escalate as appropriate. - Ensure compliance with company policies and procedures. - Perform other duties as assigned.

- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. - Proform study monitoring visits and site management for a variety of protocols, sites and therapeutic areas. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to GCP and applicable regulations. - Escalate quality issues to Project Manager (PM), Clinical Research Associate Leader (CRA Leader, if applicable), Quality Assurance (QA), Quality Management (QC) and/or Line Manager (LM) as required. - Actively participate in study team meetings and department meetings. - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans in compliance with ICH-GCP, procedural documents and local regulations both in the office and at site. - Act as a mentor of junior clinical staff including conducting co-monitoring, performance assessment and training visits, as assigned. - Act as CRA Leader to lead CRA team when assigned. - Capable on acting as a Project Leader role to manage the project at country level, as directed. - May provide assistance to the Project Manager with design of study tools, documents and processes; assist the project documents review as assigned. - Ensure compliance with company policies and procedures relating to people, finance, technology, and security at Company and the site. - Perform other duties as assigned.

- Manage the execution of the assigned clinical project(s) per service contract from initiation through closeout, ensuring that all clinical project -and project deliverables are completed with the Sponsor’s satisfaction and ensure quality deliverables on time and within budget and in accordance with SOPs, policies and procedures. - Manage and coordinate the efforts of cross-functional project teams to support milestone achievement; manage study issues and obstacles within the agreed timeline. - Develop project management plans, study tools and training materials as required, lead team assignments and accountabilities, oversight of central file maintenance. - Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. - Serve as liaisons between sponsors, investigational sites and project operational team to achieve the deliverables with quality. - Collect information on team performance against contract, customer expectations, or project baselines. Lead problem solving and resolution efforts, including management of risk, contingencies and issues. - Identify quality issues and escalate the findings within the project appropriately; implement corrective action plans through appropriate parties. - As assigned, provide input on proposal development for new business and participate in the bid-defense process under supervision. - Tracks and reports the progress of assigned clinical trials including timelines, subject enrollment target and budget adhere to the contract. - Preparation, oversight and review of project related documents within the regulated timeline. - Supervise clinical team members and assess their performance of project deliveries through daily clinical operations, provide input to line manager of project team members to identify the training needs. - Prepare and present project information at internal and external meetings. - Scheduling co-monitoring/accompanied site visits with CRA to ensure quality of study conduction at site through efficient monitoring. - Lead audit and inspection preparation, participation and follow-up - Perform other duties as assigned

Position Description: The DM & BS Associate is responsible to proceed data management activities to ensure accuracy and consistency of clinical data for subsequent analysis and reporting. The main responsibility is played as DMS (Data Management Staff) of assigned projects, who should develop plans proactively and executing accordingly, which includes the utilization of EDC system and other clinical data applications to control the process and quality of clinical data to meet the GCPs, SOPs, and related regulatory. A co-DMS will work closely with lead DMS to complete parts of data management activities per lead DMS's assignment. Staff in this position may also have to act as Database Developer, Biostatistician, Programmer when assigned. Responsibilities: 1. Design Case Report Form (CRF) / electronic Case Report Form (eCRF) and Diary Card 2. Develop Data Management Plan (DMP) 3. Defined Annotated Case Report Form (ACRF) 4. Develope Data Validation Plan (DVP) 5. Prepare SAS program of Data Validation Plan (DVP) 6. Perform visual check on SAS program of Data Validation Plan (DVP) 7. Develop Case Report Form (CRF) Completion Guideline 8. Provide project-specific Electronic Data Capture (EDC) System Training 9. Perform data clean and query process 10. Prepare / review data listings 11. Prepare for database lock 12. Quality Control data for electronic Case Report Form (eCRF) 13. Project related document and data archiving 14. Other responsibilities for Data QC Staff and Data Management Staff defined in the DM SOP 15. Play as Database Developer / SAS programmer / Biostatistician as assigned 16. The lead DMS of a project is responsible for communicating / negotiating with project team and/or sponsor. 17. The lead DMS is responsible to secure the timeline and quality of data management tasks. 18. Assist any department level operation.