Safety & PV Ops Specialist II - Technology Support (ARGUS Console or Veeva Safety preferred)

OverviewSafety & PV Ops Specialist II - Technology Support (ARGUS Console or Vault Safety preferred)ResponsibilitiesDevelops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.Ensures compliance with Standard Operating Procedures (SOP), Policies and GMP/SMP documents.Maintains knowledge of applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.Supports annual revenue targets by working with operational team members and Therapeutic BU Project Managers / Project Directors to ensure accurate and timely recognition of the BU in RBB.Provides metrics as appropriate at agreed-upon intervals based on assigned tasks.Performs other work-related duties as assigned.Technology responsibilitiesAssist with the management and maintenance of the safety database, including but not limited to: user setup and maintenance; project-specific configurations; routine safety database patches and updates; routine MedDRA and WHO drug dictionary updates; PQ scripts for safety database updates/changes; maintenance of systems to ensure compliance with reporting requirements.Assist with the management and maintenance of other SPVG applications (e.g., SharePoint).Provide project support related to safety database issues and data outputs for Safety & PvG projects utilizing the Syneos Health safety database.Assist with the execution and validation of safety data migrations into the safety database.Generate listings, reports and queries from the safety database for internal, client, or regulatory use.Participate in project meetings as requested.Ensure compliance with applicable regulatory requirements, company policies, procedures, and standards.Maintain a high level of expertise regarding Safety & PvG systems and applications through participation in internal meetings and professional seminars and workshops.Assist with other SPVG initiatives as needed.QualificationsBachelor's degree in life science, nursing, pharmacy, computer science or other technology-related field (or equivalent combination of education and experience).Safety Database systems experience and moderate medical terminology knowledge.Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), email, and internet.Ability to work independently and in a team environment; able to prioritize and manage multiple tasks.Excellent communication, presentation, interpersonal skills, both written and spoken; strong organizational and documentation skills.Detail-oriented with a high degree of accuracy and ability to meet deadlines; able to make effective decisions.Ability to manage multiple priorities.Get to know Syneos HealthSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. We are agile and driven to accelerate the delivery of therapies and are committed to helping our customers achieve their goals.Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion. The Company will determine what constitutes an equivalent qualification. This description complies with applicable laws and is intended to be consistent with local requirements.Summary: Safety & PV Ops Specialist II - Technology Support (ARGUS Console or Vault Safety preferred) #J-18808-Ljbffr