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2 semanas atrás
As a key member of our team, you will be responsible for ensuring the timely and accurate processing of operational data. Your primary objective will be to receive, triage, review and process Lifecycle safety operational data from various sources on time, within quality standards.
Key Responsibilities:- Perform data entry for tracking and Lifecycle safety databases, 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.
- Pre-process material for endpoint committee or core laboratory adjudication, preparation of material for submission, assessing 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 offices to facilitate expedited reporting, contribute knowledge and expertise to deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
- Process Lifecycle safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
- Build a positive, collaborative team environment with Lifecycle safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff.
- Good understanding of operational team on status, metrics, productivity and initiatives.
- Provide technical and process information to Lifecycle Safety Management (LSM) and members of operational team on project specific issues.
- Set up and maintain project files, standards, templates, electronic forums, databases and workflow.
- Establish and maintain effective team project service operations communications.
- Ensure compliance to high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
- Participate in training across Lifecycle safety process service offerings, participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
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