Safety & PV Specialist II

As a Safety & PV Specialist II at Syneos Health, you will play a crucial role in ensuring the safety and pharmacovigilance of projects by performing various tasks. Your responsibilities will include: - Entering information into PVG quality and tracking systems for receipt and tracking of ICSRs 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 - Triaging ICSRs, evaluating data for completeness, accuracy, and regulatory reportability - Entering data into the safety database, coding events, medical history, concomitant medications, and tests - Compiling complete narrative summaries - Assessing information to be queried and following up until queries are satisfactorily resolved - Participating in the generation of timely, consistent, and accurate reporting of expedited reports - Coordinating with data management staff for reconciliation of safety data between databases - Maintaining safety tracking for assigned activities - Performing literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding - Validating and submitting xEVMPD product records, including appropriate coding of indication terms - Identifying and managing duplicate ICSRs - Participating in activities related to SPOR/IDMP - Quality reviewing of ICSRs and work performed by peers - Acting as a subject matter expert in SPVG, resolving routine project-related queries, mentoring new hires - Ensuring distribution of all required individual expedited and periodic reports for clinical and post-marketing projects - Participating in audits/inspections as required - Ensuring relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File - Maintaining understanding and compliance with SOPs, regulations, guidelines, and project plans Qualifications: - Bachelor's Degree in life science, registered nurse, pharmacist, or equivalent - Knowledge of safety database systems and medical terminology - Understanding of clinical trial process, ICH GCP, GVP, and post-marketing safety requirements - Proficiency in Microsoft Office Suite and other relevant software - Ability to work independently and in a team environment - Excellent communication and interpersonal skills - Strong organizational skills with the ability to prioritize tasks and meet deadlines - Minimal travel may be required (up to 5%) In addition to the above responsibilities and qualifications, it is worth noting that Syneos Health is committed to developing its employees and creating a supportive work environment where diversity and inclusion are valued. Through continuous innovation and collaboration, you will have the opportunity to contribute to changing lives and making a difference in the healthcare industry.,