Requisition ID 14942BR
Title Safety Data Coordinator - Case Management I
Job Category Regulatory Affairs
Job Description PURPOSE:
The Safety Data Coordinator is responsible for the daily processing of technical complaints, non-serious adverse events and data entry of clinical Serious Adverse Event (SAE) reports. Ensures compliance with FDA regulations regarding collection, verification, and maintenance of records concerning technical complaints and adverse drug/device reports.
RELATIONSHIPS:
Reports to Product Safety Management. Internal relationships include all Product Safety personnel and personnel at all levels of the business. External relationships include the interaction with customers and external vendors.
ESSENTIAL FUNCTIONS:
Primary:
* Assists customers (both consumers and HCPs) with product related questions pertaining to technical complaints and adverse events
* Assists with maintaining complaint/AE files including archived files, on and off site.
* Collects and performs data entry on information relating to technical complaints
* Collects information (verbal or written communication) from physicians, other health-care professionals, NNI Sales personnel, and patients, for spontaneous non-serious adverse drug experiences and medical device adverse experiences associated with Novo Nordisk products
* Facilitates customer refunds and replacements on technical complaint and adverse event reports
* Generates acknowledgement letters for all technical complaint and spontaneous adverse event cases
* Generates analysis result letters, including assisting managers in preparing customized analysis letters, to send to patients and healthcare professionals.
* Generates follow-up request letters for technical complaint and adverse event cases
* Performs data entry of analysis results for spontaneous adverse events into database and prepares cases for closure
* Performs data entry of non-serious adverse events into the required complaint and safety databases
Secondary:
* Assist with various triage duties.
* Assists in identifying procedural deficiencies within the Product Safety
* Assists with department related projects.
* Creates queries for missing information on clinical SAE reports
* Performs data entry of clinical trial SAE and MESI reports into ARGUS
* Performs data entry of post marketing SAE reports into the required complaint and safety databases
* Trains personnel on technical complaints and all related complaint handling tasks
* Updates standardized letter templates as needed.
PHYSICAL REQUIREMENTS:
* May be required to work company holidays and weekends.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
* A Bachelor’s Degree preferred; a minimum of 2-4 years related experience required
* Excellent organization skills
* Intermediate proficiency required in Windows, Microsoft Word, Excel
* Strong oral and written communication skills
Department CMR - PRODUCT SAFETY (1b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required High School Education Required
Percent Travel 0 - 10%
Title Safety Data Coordinator - Case Management I
Job Category Regulatory Affairs
Job Description PURPOSE:
The Safety Data Coordinator is responsible for the daily processing of technical complaints, non-serious adverse events and data entry of clinical Serious Adverse Event (SAE) reports. Ensures compliance with FDA regulations regarding collection, verification, and maintenance of records concerning technical complaints and adverse drug/device reports.
RELATIONSHIPS:
Reports to Product Safety Management. Internal relationships include all Product Safety personnel and personnel at all levels of the business. External relationships include the interaction with customers and external vendors.
ESSENTIAL FUNCTIONS:
Primary:
* Assists customers (both consumers and HCPs) with product related questions pertaining to technical complaints and adverse events
* Assists with maintaining complaint/AE files including archived files, on and off site.
* Collects and performs data entry on information relating to technical complaints
* Collects information (verbal or written communication) from physicians, other health-care professionals, NNI Sales personnel, and patients, for spontaneous non-serious adverse drug experiences and medical device adverse experiences associated with Novo Nordisk products
* Facilitates customer refunds and replacements on technical complaint and adverse event reports
* Generates acknowledgement letters for all technical complaint and spontaneous adverse event cases
* Generates analysis result letters, including assisting managers in preparing customized analysis letters, to send to patients and healthcare professionals.
* Generates follow-up request letters for technical complaint and adverse event cases
* Performs data entry of analysis results for spontaneous adverse events into database and prepares cases for closure
* Performs data entry of non-serious adverse events into the required complaint and safety databases
Secondary:
* Assist with various triage duties.
* Assists in identifying procedural deficiencies within the Product Safety
* Assists with department related projects.
* Creates queries for missing information on clinical SAE reports
* Performs data entry of clinical trial SAE and MESI reports into ARGUS
* Performs data entry of post marketing SAE reports into the required complaint and safety databases
* Trains personnel on technical complaints and all related complaint handling tasks
* Updates standardized letter templates as needed.
PHYSICAL REQUIREMENTS:
* May be required to work company holidays and weekends.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
* A Bachelor’s Degree preferred; a minimum of 2-4 years related experience required
* Excellent organization skills
* Intermediate proficiency required in Windows, Microsoft Word, Excel
* Strong oral and written communication skills
Department CMR - PRODUCT SAFETY (1b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required High School Education Required
Percent Travel 0 - 10%