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Product Safety Investigator- - (US-NJ-NJ 1)
Compensation: $35.00 - $45.00 / Hour
Minimum Education: Bachelors
Job Type: Contract
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staffing@virtualresourcemgmt.com
Description
Product Safety Investigator Responsibilities & Job Function
• Responsible for intake of telephone and written communication from physicians, other health-care professionals, employees, clinical trial sites, CRO, and patients, in regards to spontaneous and clinical trial Adverse Drug Reactions, Medical Devices Experiences, and technical reports associated with products.
• Work directly with Managers, Product Safety. Upon requests, provide approved product safety related information e.g. product analysis to Health-Care professionals and patients.
• Conduct investigations into adverse drug and device reports with products with respect to applicable Federal regulations (IND, NDA, MDR, GMP) and internal Standard Operating Procedures. Triage adverse medical events and malfunction reports with respect to FDA report ability (i.e., 7 day, 15 day, MDR). Submit spontaneous and clinical trial reports of deaths and serious events to IPS per current agreement.
• Responsible for preparation of NDA, MDR and IND Accelerated Safety Reports. Process AE and SAE case closures as outlined in Standard Operating Procedures. Communicate with reporter or complainant, the need for additional medical and/or supplementary information relevant to the report. Communicate with NNI or NNAS personnel as to status of complaint investigation, course of action, recommendation, and/or the need for additional medical and/or supplementary information relevant to the report. Communicate with NNAS Quality departments (Drug and Device) as to the status of product analysis and the need for additional information relevant to the report.
• Participate in clinical development teams as necessary to assure proper collection and reporting of clinical study adverse event data. Assist manager with providing technical direction to Product Safety & Surveillance support personnel. Assist manager with Product Safety & Surveillance presentations or training seminars as necessary. Complete special projects as required.
Minimum Requirements
• Bachelor of Science in health/life sciences required. Registered Nurse, Pharmacist, other health care professionals, or advanced degrees preferred.
• Minimum 2 years of prior experience required, specifically in pharmacy practice, clinical or product safety.
• Exceptional knowledge of medical terminology and MedDRA coding
• Recent experience with MS Office products, particularly Excel, Word and Outlook.
Additional Requirements
• Outstanding customer service abilities, enabling you to remain professional and avoid conflict.
• Commitment to quality, a 'do what it takes' mindset and positive attitude.
• Attention to detail and skill at auditing to ensure accuracy.
• Team approach to work environment - encouraging collaboration, fairness, trust and support.
• Self-motivated; proactive approach to process improvement through effective and efficient work processes.
• Makes good decisions and shares findings based upon analysis, wisdom, experience and judgment when servicing customers and participating in project teams.
• Has functional and technical knowledge and skills to do the job at a high level of accomplishment and maintains that knowledge on a constant basis.
• Provides direct feedback and information to customers in a timely manner.
Glenn McClain
Virtual Resource Management Corporation
P.O. Box 598
Clarksburg, NJ 08510
Fax: 609-228-5002
Phone: 609-208-0333
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