Product Safety Data Coordinator and Coding Associate – Remote (onsite in NJ 1 day per week)
1-3 year Contract
Competitive Hourly Rates
Duties:
Data entry into the Product Safety database for Adverse Events reported in association with 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 SOPs.
Requirements:
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 communication skills
• 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.
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. There is a template but you need to know what to enter in the template and where. An example is if someone reports a fuzzy head as opposed to a headache, this individual would need to know how to code this.
This team takes care of approx. 7-10 cases per day. The team is also in constant contact with the manager several times per day since this position is mainly done off site.
NOTE: 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.
