Product Safety Data Coordinator

Job Description:

• Data entry into the Product Safety database for Adverse Events reported in association with Client s Marketed and investigational products. 

• The activities include, but are not limited to, data entry, coding into standard dictionaries and writing of narratives based on information provided both on standard forms and from medical records and other documents.

• The individual will be responsible for verifying the accuracy and completeness of information for each adverse event report for which he/she is responsible in conjunction with the source documents and ensuring that the activities are performed in a manner consistent with Client s SOPs.

• Following successful training, the candidate will be expected to work from home with the requirement to come into the Woodcliff Lake office on Wednesdays each week.

• Health Care Professional (with or without previous drug safety experience) or non- health Care Professional with previous drug safety experience desired Medical terminology understanding required, with proficiency with MedDRA or doing into other standard medical coding dictionary preferred 2-3 year s minimum experience in medical coding/terminology/data entry within a pharmaceutical organization.

• Computer proficiency required, including data entry into standardized electronic databases STRONG WRITTEN AND VERBAL COMMUNICATIONS ARE ESSENTIAL Experience with data entry into drug safety databases such as ARISg/ARGUS, preferred.

• Strong attention to detail and accuracy Strong proofreading, editing and reviewing skills are essential Must be able to work independently, and possess problem solving skills, but also know when to seek assistance from manager.

• At Client there are two groups in this department. The one group takes the reports and enters the data into the system. They consider that more of a coordinator position only. This role is more involved because it requires analysis of the narrative on the reports

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3348 | Fax: 973.998.2599

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