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Requisition ID 33034BR
Title Safety Data Specialist - Case Man II
Job Category Regulatory Affairs
Job Description PURPOSE:
Responsible for the daily processing of post-marketing and clinical trial adverse events. To ensure compliance with FDA regulations regarding collection, verification, and maintenance of records concerning adverse drug/device reports. Responsible for telephone and written communication with physicians, other health-care professionals, Novo Nordisk employees, clinical trial sites, CROs, and patients, in response to spontaneous and clinical trial adverse drug experiences and medical device experiences, and technical reports associated with Novo Nordisk products.
Reports to Product Safety management. Internal relationships include all Product Safety personnel and personnel at all levels of the business regarding to product safety and surveillance issues. External relationships include interaction with regulatory institutions such as the FDA, CROs, vendors and GS.
PRIMARY: Assist with preparation of NDA, MDR and IND Expedited Safety Reports
PRIMARY: Creates queries for missing information on clinical SAE reports
PRIMARY: Extracts records from EDC system, including query responses, for data entry into safety database
PRIMARY: Participate in clinical development teams as necessary to assure proper collection and reporting of clinical study adverse event data
PRIMARY: Process AE and SAE case closures as outlined in Standard Operating Procedures
PRIMARY: Submit adverse event reports from clinical trials to GS per current agreement
PRIMARY: Triage all Product Safety Investigator tasks and performs case classification, work assignment and daily resource allocation. Triage ensures that all new relevant case information is processed and registered in the relevant safety databases. Ensures that all related tasks are handled within specified timelines with respect to FDA regulations
PRIMARY: Verify data entered for clinical trial SAE and MESI reports into safety database
SECONDARY: Assist manager with Product Safety presentations or training sessions as necessary
SECONDARY: Based on an evaluation of adverse drug and device reports with Novo Nordisk products request additional relevant information from patients and healthcare professionals with respect to applicable Federal regulations (IND, NDA, MDR, GMP) and internal Standard Operating Procedures
SECONDARY: Collects information (verbal or written communication) from physicians, other health-care professionals, NNI Sales personnel, and patients, for post-marketing serious adverse drug experiences and medical device adverse experiences associated with Novo Nordisk products
SECONDARY: Communicate with Global Safety regarding the status of case analysis and the need for additional information relevant to the report
SECONDARY: Communicate with NNI or NNAS personnel as to status of complaint investigation, course of action, recommendation, and the need for additional medical or other supplementary information relevant to the report
SECONDARY: Complete special projects as required
SECONDARY: Perform case data clean-up prior PSUR and PADER submissions to health authorities
SECONDARY: Performs data entry of serious post-marketing adverse events into the required complaint and safety databases
SECONDARY: Upon request, provide approved product safety related information e.g. product analysis to Health-Care professionals and patients
SECONDARY: Verify data entered for non-serious adverse events into safety database
May be required to work company ...cont.
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