Job
Description
You will be responsible for the following tasks: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assisting in the preparation of project plans such as Safety Management Plan - Performing set-up, delivery, and close-out of safety and pharmacovigilance projects - Processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triageing ICSRs and evaluating ICSR data for completeness, accuracy, and regulatory reportability - Entering data into safety database - Coding events, medical history, concomitant medications, and tests - Compiling complete narrative summaries - Assessing information to be queried and following up until information is obtained and queries are satisfactorily resolved - Generating timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements - Coordinating with data management staff concerning reconciliation of safety data between the clinical and safety databases - Maintaining safety tracking for assigned activities - Performing literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required - Validating and Submitting xEVMPD product records, including appropriate coding of indication terms using MedDRA - Manual recoding of un-recoded product and substance terms arising from ICSRs - Identifying and managing duplicate ICSRs - Participating in activities related to SPOR / IDMP - Quality reviewing ICSRs and the work performed by peers - Serving as a subject matter expert in SPVG, resolving project-related routine queries, and mentoring, coaching, and training new hires - Fostering constructive and professional working relationships with all project team members, internal and external - Applying safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities - Ensuring distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports - Participating in audits/inspections as required - Ensuring 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 - Maintaining 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 Qualifications required for this role: - Bachelor's Degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience - 3-5 years of relevant Safety/Pharmacovigilance-ICSR-Case processing experience - Experience in Safety Database systems (ARGUS) and knowledge of medical terminology - Good understanding of 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, email (Outlook), TeamShare, and internet - Ability to work independently and in a team environment - Excellent communication and interpersonal skills, both written and spoken - Good organizational skills with proven ability to prioritize and work on multiple tasks and projects - Detail-oriented with a high degree of accuracy and ability to meet deadlines - Minimal travel may be required (up to 5%) You will be responsible for the following tasks: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assisting in the preparation of project plans such as Safety Management Plan - Performing set-up, delivery, and close-out of safety and pharmacovigilance projects - Processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triageing ICSRs and evaluating ICSR data for completeness, accuracy, and regulatory reportability - Entering data into safety database - Coding events, medical history, concomitant medications, and tests - Compiling complete narrative summaries - Assessing information to be queried and following up until information is obtained and queries are satisfactorily resolved - Generating timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements - Coordinating with data management staff concerning reconciliation of safety data between the clinical and safety databases - Maintaining safety tracking for assigned activities - Performing literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required - Validating and Submitting xEVMPD product records, including appropriate coding of indication terms using MedDRA - Manual recoding of
