Graduate, Operations Specialist 1 - Regulatory Reporting (Pharmacovigilance) - FTC
- Experience Level
- Entry level
External Job Description
Regulatory Reporting – Graduate, Operations Specialist 1
11 Month Fixed Term Contract
Use your scientific and healthcare degree to join the world’s leading comprehensive pharmaceutical safety services organization on a fast-growing team performing Regulatory Reporting submissions.
Be a part of a global team to help ensure the safety profile of a COVID-19 vaccine with opportunities to improve worldwide public health.
Review, assess and process Lifecycle Safety data and information, across all 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.
Receive, triage, review and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of primary review.
Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting.
Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
Assist operations team with tasks, provide for back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes.
Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate.
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.
Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
May liaise with client in relation to details on day to day process of cases.
Perform operational and collaborative LSM task as directed by Lifecycle Safety Infrastructure.
Ensure compliance to Quintiles high quality standards and work with LSM constructively in a matrix framework to achieve project and customer deliverables.
Executes administrative operational tasks as required e.g. committee and laboratory management.
Collaborate with SO and LSM to help achieve operational departmental goals i.e. understands metrics appropriate to quality document management and assist in the achievement of productivity utilization and realization metrics.
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.
Perform other duties as assigned.
Required Knowledge, Skills and Abilities:
Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
Ability to meet strict deadlines; manage competing priorities and changing demands.
Sound organization and time management skills.
Ability to follow instructions/guidelines, work independently and on own initiative.
Good attention to detail and accuracy and maintain high quality standards.
Demonstrate good IT skills.
Effective written and verbal communication skills.
Ability to be flexible and receptive to changing process demands.
Willingness and aptitude to learn new skills across Lifecycle Safety service lines.
Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Minimum Required Education :
Bachelor’s Degree in scientific or healthcare discipline
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – 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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.