Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post : Adjudication Coord II
Job Description
• 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:
• 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:
• Implementation of adjudicator disagreement resolution processes.
• Implementation of re-review and re-adjudication processes.
• 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:
• Identification and screening of potential adjudicators.
• Collection of signed Confidentiality Disclosure Agreements, CVs, completed Adjudicator Selection Questionnaires, signed Contracts from potential adjudicators.
• 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 (WIs).
• Build and maintain good working relationships within Adjudication Services department and across functional units.
• Any other duties as assigned by management
Candidate Profile
• Non-Degree +6 years relevant experience** (or 6 years adjudication experience*)
• Associates Degree +4 years relevant experience (or 4 years adjudication experience)
• B/BS Degree +2 years relevant experience (2 years adjudication experience)
• RN +0 years relevant experience (0 years experience)
• Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
• Adjudication experience includes direct experience receiving and processing events for adjudication, working to collect event data and documents required for adjudication, working within adjudication event tracking systems.
• Relevant experience includes experience in the pharmaceutical, biotechnology, CRO, or ARO industry in related areas, such as: Clinical, Safety, Data Management
• 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.
Additional Information
Experience : 0-5+ years
Qualification : B.Pharm, B.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th October, 2019
See All M.Pharm Alerts M.Sc Alerts B.Pharm Alerts B.Sc Alerts
See All Other Jobs in our Database
.png)
