Artech Information System LLC
Safety Surviellance Associate
Artech Information System LLC, Java Village, New York, United States
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Primary Responsibilities: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pharmaceutical products and to meet regulatory requirements. Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately. Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Generate reports, ensuring adherence to regulatory compliance timelines. Liaise with key partners regarding safety data collection and data reconciliation. Develop and maintain expertise and knowledge of all assigned products within a therapeutic area and applicable regulations. Qualifications
Technical Skill Requirements: Experience in Pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement. Demonstrated computer literacy, particularly in the use and management of relational databases. Ability to achieve personal objectives while meeting departmental standards of performance. Excellent oral and written communication skills. Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification. Additional Information
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 Connect with us on - LinkedIn | Facebook | Twitter
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Primary Responsibilities: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pharmaceutical products and to meet regulatory requirements. Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately. Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Generate reports, ensuring adherence to regulatory compliance timelines. Liaise with key partners regarding safety data collection and data reconciliation. Develop and maintain expertise and knowledge of all assigned products within a therapeutic area and applicable regulations. Qualifications
Technical Skill Requirements: Experience in Pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement. Demonstrated computer literacy, particularly in the use and management of relational databases. Ability to achieve personal objectives while meeting departmental standards of performance. Excellent oral and written communication skills. Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification. Additional Information
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 Connect with us on - LinkedIn | Facebook | Twitter
#J-18808-Ljbffr