TCU Validation Resource Job

TCU Validation Resource is needed to perform the following duties:

· Receive, triage, review and process data from various sources

· Perform data entry for tracking and safety database, coding relevant medical terminology, writing descriptive 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

· Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.

· Identify AE, seriousness, expectedness for case assessment; review additional incoming information to determine reportability

Select the appropriate as reported and company causality
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.
· 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.

· 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.

· 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.

· Perform all appropriate coding using MedDRA, WHO-DRUG, and Company Product dictionaries.

· 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.

· Perform operational and collaborative LSM task as directed by Lifecycle Safety Infrastructure.

Assist in writing late ICSR related deviations and CAPAs, upon request
· Perform CRO case QC activities, reconciliation etc as required.

· Ensure compliance to IQVIA high quality standards and work with LSM constructively in a matrix framework to achieve project and customer deliverables.

· Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.

· 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.

Bachelor's Degree is required in Pharmacy or Pharmaceuticals Engineering or Pharmaceutical Science

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave