Operations Specialist 1 (Pharmacovigilance)

About the role

IQVIA is hiring an Operations Specialist 1 in Tokyo 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 operations 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 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.
• Create, maintain and track cases, identify quality problems and report them to a senior team member.
• Liaise with project management, clinical and data management teams, and with investigators, medical monitors and site coordinators; may liaise with the client on day-to-day case processing.
• Mentor new team members if assigned, attend project meetings and give feedback to the operations manager.
• Lead or support department initiatives and perform other duties as assigned.

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.
• High school diploma or equivalent in a scientific or healthcare discipline or allied life sciences.
• Good knowledge of medical terminology and working knowledge of applicable safety databases and client applications.
• Knowledge of global, regional and local clinical research regulatory requirements.
• Ability to work in shifts, sit for long periods, use the keyboard extensively and occasionally travel.

Required skills

• Working knowledge of Microsoft Office and web-based applications.
• Strong attention to detail, accuracy and organizational skills.
• Excellent verbal and written communication, and ability to multi-task and meet strict deadlines.
• Willingness to learn across safety service lines and to work as a team player.