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Operation Specialist 1

Job description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

• To Prioritize and complete the assigned trainings on time.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
• Ensure to meet quality standards per project requirements.
• Ensure to meet productivity and delivery standards per project requirements.
• To ensure compliance to all project related processes and activities.
• Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
• Creating, maintaining and tracking cases as applicable to the project plan.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• To demonstrate problem solving capabilities.
• Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
• May liaise with client in relation to details on day to day case processing activities.
• To mentor new teams members, if assigned by the Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• Perform other duties as assigned.

• Good knowledge of medical terminology
• Working knowledge of applicable Safety Database and any other internal/Client applications.
• Knowledge of applicable global, regional, local clinical research regulatory requirements
• Excellent attention to detail and accuracy; maintain high quality standards
• Good working knowledge of Microsoft Office and web-based applications
• Strong organizational skills and time management skills
• Strong verbal/written communication skills
• Self-motivated and flexible
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands
• Ability to delegate to less experienced team members
• Ability to be flexible and receptive to changing process demands.
• Willingness and aptitude to learn new skills across Safety service lines
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients
• Ability to work as a Team Player, contribute and work towards achieving Team goals
• • Ensure quality of deliverables according to the agreed terms
• Demonstration of IQVIA core values while doing daily tasks

• Extensive use of keyboard requiring repetitive motion of fingers.
• Exte nsive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Operation Specialist 1

Kochi, Kerala
Full Time

Published on 08/04/2020