Operations Specialist 1

Operations Specialist 1

3-6 years
Not Specified

Job Description

Job Overview
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 Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.
Essential Functions
. 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 IQVIA 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.
. Lead/ Support department Initiatives
. 100% compliance towards all people practices and processes
. High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req
. Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience.
. r equivalent combination of education, training and experience.
. 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.
. Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
. Regular sitting for extended periods of time.
. May require occasional travel.
. Flexibility to operate in shifts.

Job Details


At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible â€' to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

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