Safety & PV Specialist I

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. Your responsibilities will include entering information into PVG quality and tracking systems, processing ICSRs according to SOPs, and evaluating ICSR data for completeness and accuracy. You will be responsible for triaging ICSRs, entering data into safety databases, coding events, medical history, and concomitant medications, as well as compiling complete narrative summaries. Additionally, you will be involved in identifying information to be queried, following up until resolution, and generating timely and accurate expedited reports in compliance with regulatory requirements. Your role will also involve maintaining safety tracking for assigned activities, performing literature screening and review for safety, drug coding, and MedDRA coding as required. You will validate and submit xEVMPD product records, manually recode un-recoded product and substance terms from ICSRs, identify and manage duplicate ICSRs, and conduct activities related to SPOR/IDMP. Furthermore, you will ensure the submission of all relevant documents to the Trial Master File and the Pharmacovigilance System Master File, while maintaining compliance with SOPs, global regulations, and guidelines. You will foster professional relationships with project team members, participate in audits as required, and apply safety reporting regulatory intelligence to all safety reporting activities. To excel in this role, you should possess a Bachelor's Degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience. A minimum of 3 years of experience in ICSR is required, along with a good understanding of clinical trial processes, ICH GCP, GVP, and safety regulations. Proficiency in Microsoft Office Suite, excellent communication skills, the ability to work independently and in a team environment, and strong organizational skills are essential. Join Syneos Health, a company dedicated to accelerating customer success by translating insights into outcomes and creating a diverse and inclusive workplace where everyone feels like they belong. If you are passionate about making a difference in the lives of others, apply now and be a part of our team that is committed to changing lives through innovative solutions.,