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Data Entry Coordinator

Newark Metro Area, NJ

Posted: 04/15/2019 Job Type: Scientific Job Number: JN -042019-24655
Description:

REQUIRED KNOWLEDGE/SKILLS/ABILITIES:
BS degree required
Clinical Knowledge of therapeutic area patient populations and drug class
Knowledge and sensitivity of global cultures applicable to local case handling
REQUIRED - Proficiency in technical safety systems including ARISg, ARGUS and
medical coding
Computer and database skills
Records management experience
Knowledge of Medical Terminology
Knowledge of laboratory, diagnostic testing and ability to read discharge summaries.


KEY ACTIVITIES:
AE Case Management:
Conduct full data entry from serious and clinical
source documents as per the Global Drug Safety and Risk Management conventions -all cases globally including complex cases involving medical records and literature cases
Interpretation of medical source documents for data entry into the safety database including extraction of appropriate laboratory data and diagnostic testing
Identify and confirm the appropriate timeline path for all cases based on the serious criteria
Ensure the adherence to internal and external timelines for case processing to maintain regulatory reporting compliance
Identify case sources as defined by GDSRM conventions
Utilize clinical tracking databases to retrieve study information for entry into the safety database
Review and resolve ARISg validation errors
QC of receipt data which includes receipt date, identification of product quality complaints
Liaise with the Workflow Manager to resolve processing and workflow issues

Internal Global Safety Department Development:
Demonstrate knowledge of and compliance with conventions having departmental impact.
Draft conventions documentation as required
Contribute to proactive identification of areas requiring new conventions or revision of current conventions
Actively participate in and utilize knowledge from departmental training initiatives.
Pro-actively utilize experience to identify pertinent medical information, laboratory results, diagnostic tests and hospitalization records

RESPONSIBILITIES:
Data entry aspects of AE handling
Consistent process practices globally
Process timelines consistent with regulatory compliance on a global level
Process standards and practices
Quality data entry

EXPECTED COMPETENCIES:
Time management
Ability to multi-task and prioritize
Communication (written and oral)
Functions autonomously
Strong team work
Ability to comprehend and comply with established internal processing timelines
Compliance with SOPs/WPs
Ability to maintain consistency in productivity level in a fast- paced work environment
Possess good analytical skills
Strong professional inter-personal skills demonstrated by daily interactions with co-workers
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