Safety Data Specialist - Case Management II Job at Princeton

Requisition ID 14940BRTitle Safety Data Specialist - Case Management IIJob Category Regulatory AffairsJob 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.RELATIONSHIPS: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.ESSENTIAL FUNCTIONS:Primary:* Participate in clinical development teams as necessary to assure proper collection and reporting of clinical study adverse event data* Verify data entered for clinical trial SAE and MESI reports into safety database* Extracts records from EDC system, including query responses, for data entry into safety database* Creates queries for missing information on clinical SAE reports* 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* Submit adverse event reports from clinical trials to GS per current agreement* Assist with preparation of NDA, MDR and IND Expedited Safety Reports* Process AE and SAE case closures as outlined in Standard Operating ProceduresSecondary:* Assist manager with Product Safety presentations or training sessions as necessary* 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* Performs data entry of serious post-marketing adverse events into the required complaint and safety databases* Verify data entered for non-serious adverse events into safety database* Perform case data clean-up prior PSUR and PADER submissions to health authorities* 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* Communicate with Global Safety regarding the status of case analysis and the need for additional information relevant to the report* 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* Complete special projects as required* Upon request, provide approved product safety related information e.g. product analysis to Health-Care professionals and patientsPHYSICAL REQUIREMENTS:* May be required to work company holidays and weekends.KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:* A Bachelor of Science in health or life sciences and four years experience required; or a Registered Nurse, Pharmacist, other health care professional, or advanced degree preferred with a minimum of 2 years experience; specifically in pharmacy practice, clinical practice, or product safety.* Exceptional knowledge of medical terminology and MedDRA coding* Recent experience with MS Office products, particularly Excel, Word and OutlookDepartment CMR - PRODUCT SAFETY (1c)Position Location US - Princeton, NJCity PrincetonState/Provinces US - NJDegree Required Bachelors Degree RequiredPercent Travel 0 - 10%
Country: USA, State: New Jersey, City: Princeton, Company: Novo Nordisk Inc..