Job Description
Candidates with Permanent Residence Status (Citizen/ Green Card) and Healthcare/ Pharmaceutical Industry background preferred.
Position: Drug Safety Coordinator
Duration: 6 + months
Location: Morris Plains, NJ
Description:
Responsible for the receipt and data entry of ADVERSE EVENT reports following company standard operating procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies
Principal Responsibilities include:
Data management, report preparation and appropriate dissemination of spontaneous non- serious and serious adverse event information for legacy consumer healthcare products.
Activities include:
Duplicate check and commit contact information from initial and follow-up source documents into the adverse event database
Forward cross reference email with assigned data base number to reporter for ex-US contacts
Prepare a clinical narrative (CIOMS/3500A) and independently assign MedDra terms and labeling to adverse events while maintaining compliance timelines
Liaise with the SA point person for Triage
Quality review is limited to review of their own work
Requests deletions as necessary
Supports aggregate report writing via data integrity changes
All other duties as assigned
Processes and Procedures
Definition: Understand and follow BRM systems and procedures
SOP: Standard operating procedure awareness
SWP: standard working practice awareness
Guidance Documents
Forms
Job Requirements
Education & Experience requirements:
Bachelor of Science degree (or equivalent experience)
Previous experience using medical terminology and MedDra coding desired
Applied knowledge of global regulations and global compliance timeline desired
Required Skills/ Abilities:
Working knowledge of data management systems
Excellent oral and written skills
Decision making skills
Quality orientation
3 years experience
To further discuss this opportunity; please send me your most recent resume in a MS Word format to [Click Here to Email Your Resumé]. Also, please take a few minutes to answer some of the questions below; they will help me qualify you candidature quickly.
Full Legal Name
Preferred email ID:
Day/ Evening phone numbers:
Current Location:
Work Authorization:
Earliest availability for Phone/ On-Site interview:
Hourly Rate on W2:
Earliest possible start date:
Also, be aware that our client conducts a criminal background check/ Test for Drug Abuse on candidates who are extended offers of employment. Therefore, before we proceed with your candidacy regarding this project opportunity, please advise us now if you have any felonies or misdemeanors.
About Us:
We are a mid sized 75 million IT services Company head quartered out of Herndon, Virginia. Geographically we are spread is 10 offices in US and 6 global software development centers. We have been rated as the 4th fastest growing private company in America by INC 500. We have consistently featured in the Deloitte fast 50 list and have been ranked as the 3rd largest technology company in Virginia in the most recent one. Currently we have about 650 technology consultants on billing across our client sites in the US. Our Client base consists of Fortune 100 like Verizon, CapitalOne, Fannie Mae, J&J, EDS, Accenture, Lockheed Martin, Raytheon to name a few. LanceSoft’s dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. For those who are looking for Visa sponsorship, we do sponsor H-1, TN, as well as Green Card for qualified candidates.
I look forward to work with you and, encourage you to visit our website www.lancesoft.com to learn more about LanceSoft as an organization.
Regards,
Himanshu Patel
180 Mount Airy Road, Suite 104, Basking Ridge, NJ 07920
W# 908-953-0392 M# 732-593-7029 Fax: 908-766-0969
[Click Here to Email Your Resumé] | www.lancesoft.com
Technology | Consulting | BPO
USA | UK | Asia-Pac | South Africa
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