Operation Specialist - Pharmacovigilance

About the role

iQVIA is looking for an Operation Specialist in Dalian to review, assess and process safety data and information received from various sources, then distribute reports and data internally and to external third parties in line with regulations, SOPs and internal guidelines, under the guidance of senior operation team members.

Key responsibilities

• Process safety data according to regulations, guidelines, SOPs and project requirements, and complete assigned trainings on time.
• Perform pharmacovigilance activities such as collecting and tracking incoming adverse event (AE) and endpoint information, determining initial and updated status, database entry, coding AEs and products, writing narratives and literature-related activities.
• Ensure quality, productivity and delivery standards, and comply with all project processes; read and acknowledge relevant SOPs and complete required training.
• Create, maintain and track cases, identify quality problems and share them with a senior team member, and liaise with project management, clinical, data management and healthcare professionals, and sometimes with the client.
• Attend project team meetings, give feedback to the operations manager, mentor new team members if assigned, and lead or support department initiatives.
• Depending on project needs, review non-serious AEs and ADRs, including coding, medical history, concomitant medications, expectedness, causality and other medical information, and document all communications.

Required profile

• Bachelor's degree in life sciences or a related field, with up to 3 years of relevant experience, including up to 1 year of pharmacovigilance experience, or an equivalent combination of education, training and experience.
• Good knowledge of medical terminology.
• Knowledge of global, regional and local clinical research regulatory requirements.
• Ability to work independently, multi-task, meet strict deadlines and work in shifts; occasional travel may be required.

Required skills

• Working knowledge of safety databases and other internal or client applications.
• Good working knowledge of Microsoft Office and web-based applications.
• Strong attention to detail, organizational and time-management skills, and good verbal and written communication.