Job Overview The Pharmacovigilance and Case Intake Specialist/Operations Specialist 1 reviews, assesses, and processes safety data. This role involves distributing reports/data to internal and external parties, following regulations, SOPs, and guidelines with support from senior team members.
Essential Functions Complete assigned training on time.Process safety data per regulations, guidelines, SOPs, and project requirements.Perform pharmacovigilance activities, including:Collecting and tracking Adverse Events (AEs).Determining status of incoming events.Database entry and coding AEs/products.Writing narratives and conducting literature-related activities.Ensure quality and productivity standards are met.Comply with all project-related processes and activities.Read and acknowledge necessary SOPs and ensure timely training.Create, maintain, and track cases.Identify and report quality issues.Demonstrate problem-solving skills.Liaise with team members and healthcare professionals to address project issues.May liaise with clients on case processing activities.Mentor new team members if assigned.Attend project meetings and provide feedback.Perform other duties as assigned.Lead/support department initiatives.Ensure compliance with all people practices and processes.Perform medical review of non-serious AEs and ADRs as required.Qualifications Bachelor's degree in life sciencesUp to 1 year in pharmacovigilance and/or intake case processingAdvanced level of EnglishGood knowledge of medical terminology and safety databases.Knowledge of global, regional, and local clinical research regulations.Excellent attention to detail and accuracy.Strong organizational, time management, and communication skills.Self-motivated, flexible, and able to work independently.Ability to multi-task, meet deadlines, and manage competing priorities.Ability to delegate and adapt to changing demands.Willingness to learn new skills across safety service lines.Ability to establish effective working relationships with coworkers, managers, and clients.Team player with a focus on quality deliverables.Demonstration of core values in daily tasks.Extensive use of telephone and face-to-face communication.Regular sitting for extended periods.May require occasional travel and flexibility to operate in shifts.
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