Data Entry Coordinator - ARISg, ARGUS, medical coding at Apex Systems, Inc. in Summit, NJ

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  • 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
  • Conduct full data entry from serious and clinical source documents as per the Global Drug Safety and Risk Management conventions
  • 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
  • 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


  • BS degree required
  • Clinical Knowledge of therapeutic area patient populations and drug class
  • Knowledge and sensitivity of global cultures applicable to local case handling
  • Proficiency in technical safety systems including ARISg, ARGUS and medical coding required
  • Computer and database skills
  • Records management experience
  • Knowledge of Medical Terminology
  • Knowledge of laboratory, diagnostic testing and ability to read discharge summaries.
  • Ability to multi-task and prioritize with excellent time management
  • Excellent communication both 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

***For immediate consideration, please email your updated resume to with "Data Entry Coordinator" in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.

VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

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