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 from various sources according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
To perform Pharmacovigilance activities per project requirement including but not limited to, intake and tracking incoming - Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry including coding AE, Products, Medical history and labs, writing narratives, and other project activities as per internal/ project timelines.
Assess Lifecycle Safety data for reportability to relevant authorities and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local IQVIA offices to facilitate expedited reporting.
Ensure to meet quality standards per project requirements. Identify quality problems, if any, and bring them to the attention of a senior team member.
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.
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.
Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
Qualifications
Bachelor's degree in pharmacy, life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience.
Good knowledge of medical terminology.
Working knowledge of applicable Safety Database and any other internal/Client applications.
Basic 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 verbal/written communication skills.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
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 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.
Demonstration of IQVIA core values while doing daily tasks - Extensive use of keyboard requiring repetitive motion of fingers.
Flexibility to operate in shifts.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
