# Safety & PV Coordinator - Clinical Trial Case Processing **Company**: Syneos Health **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/Safety---PV-Coordinator---Clinical-Trial-Case-Processing--1--Year-Experience-_25110338?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_7d3bdec1-8f9 ## Description Syneos Health is seeking a Safety & PV Coordinator - Clinical Trial Case Processing. As a member of the Clinical Solutions team, you will act with a drug development mindset, applying your years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. **Job Responsibilities** - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required - Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory report ability - Enter data into safety database - Code events, medical history, concomitant medications, and tests - Compile complete narrative summaries - Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved - Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements - Maintain safety tracking for assigned activities - Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required - Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA - Manually recode un-recoded product and substance terms arising from ICSRs - Identify and manage duplicate ICSRs - Participate in activities related to SPOR / IDMP - Conduct quality review of ICSRs - Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate - Maintain understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process - Foster constructive and professional working relationships with all project team members, internal and external - Participate in audits as required/appropriate - Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities **Qualifications** - Bachelor’s Degree in Life Sciences, Nursing, Pharmacy, or an equivalent combination of education and experience that provides the necessary knowledge, skills, and abilities to perform the job - 1+ years of experience in Clinical Trial Case Processing, including adverse event case handling, safety data review, and pharmacovigilance activities - Experience with Safety Database systems and knowledge of medical terminology required - Good understanding of the clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH-GCP, GVP, and regulations related to Safety and Pharmacovigilance - Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, Outlook, Team Share (or other shared content/workspace management tools), and internet-based applications - Ability to work independently and in a team environment - Excellent communication and interpersonal skills, both written and verbal - Good organizational skills with a proven ability to prioritize and manage multiple tasks and projects simultaneously - Detail-oriented with a high degree of accuracy and the ability to meet deadlines ## Skills ### Required - Life Sciences - Nursing - Pharmacy - Clinical Trial Case Processing - Safety Database systems - Medical terminology - ICH-GCP - GVP - Microsoft Office Suite --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/Safety---PV-Coordinator---Clinical-Trial-Case-Processing--1--Year-Experience-_25110338?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)