Covance

Adjudication Coord II

Job Location(s) IN-Bangalore
Job Number
2021-72358
Job Category
Drug Safety/Pharmacovigilance
Position Type
Full-Time
Telecommute
No

Job Overview

Responsible for providing coordination and support of projects operated by the Adjudication Services department, to ensure smooth delivery and achievement of the objective that all adjudication events are processed and submitted for adjudication within the agreed upon procedures, timelines, budget and quality standards.
This post holder is responsible for providing this service for client projects, either as a support function to the client project groups or as stand-alone business.
This post holder operates under limited guidance by Adjudication Services project leadership and/or Adjudication Services management.
This post holder is typically assigned to a number of concurrent projects which are typically moderate-to-high with respect to scale, scope and complexity
- Operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).
- Perform processing of adjudication events. This includes, but is not limited to: o Maintaining event tracking systems.
 Event case processing: intake and triage, event linking, event de-activation, tracking, data entry, document processing (e.g. redaction of specified content), review of incoming event information for completeness and accuracy, content review, identification of missing required data and/or documents, generation of queries, query review and closure/re-issue.
 Contacting site personnel to obtain missing data and/or documents.  Escalating open events for issue resolution and closure, in accordance with relevant Escalation Plan.
 Completing First Review QC Checklists or Second Review QC Checklists (as appropriate), assembling dossiers.
 Conducting event reconciliation processes.
- Coordinate implementation of adjudicator workflows. This includes, but is not limited to: o Implementation of adjudicator disagreement resolution processes. o Implementation of re-review and re-adjudication processes. o Processing of adjudicator requests for additional documentation.
- Processing of adjudicator notifications of potential un-reported events.
- Prepare event adjudication status reports and metrics.
- Conduct adjudication committee compilation processes. This includes, but is not limited to: o Identification and screening of potential adjudicators.
- Collection of signed Confidentiality Disclosure Agreements, CVs, completed Adjudicator Selection Questionnaires, signed Contracts from potential adj udicators.
- Provide mentoring and quality control for less experienced Adjudication Services staff, as appropriate.
- Work in accordance with the Standard Operating Procedure (SOP) system, including departmental Work Instructions (W Is).
- Build and maintain good working relationships within the Adjudication Services department and across functional units.
Any other duties as assigned by management

Education/Qualifications

Minimum Required:
Master or Bachelor degree in life sciences 
 

Experience

Minimum Required:
- High degree of accuracy with close attention to detail.
- Functions as a strong team player.
- Ability to work efficiently with limited guidance.
- Ability to effectively balance multiple concurrent priorities.
- Ability to present and share useful business information across departments and functions.
- Ability to anticipate and identify problems and take appropriate action to correct.
- Strong written and verbal communication skills. Knowledge of medical terminology.
- Knowledge of hospital documentation practices.
- Knowledge of Good Clinical Practice (GCP).
- Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.
- Good keyboard skills with knowledge of MS Office and Windows applications beneficial.

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