Operations Specialist
QuintilesIMS
Shanghai, China
4天前

Descripción del trabajo

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.

  • 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, 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.
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