Requisition ID 43436BR<br/>Title Specialist - Safety Data Case Management III<br/>Job Category Pharmacovigilance<br/>Job Description PURPOSE:<br/>Responsible for the daily processing of post-marketing and clinical trial adverse events. Ensures 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.<br/><br/>RELATIONSHIPS:<br/>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.<br/><br/>ESSENTIAL FUNCTIONS:<br/>* 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.<br/>* Performs data entry and verification of serious post-marketing adverse events into the required complaint and safety databases.<br/>* Perform case data clean-up prior PSUR and PADER submissions to health authorities.<br/>* 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.<br/>* 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.<br/>* Submit adverse event reports from clinical trials to GS per current agreement.<br/>* Assist with preparation of NDA, MDR and IND Expedited Safety Reports.<br/>* Process AE and SAE case closures as outlined in Standard Operating Procedures.<br/>* Assist manager with Product Safety presentations or training sessions as necessary.<br/>* Participate in clinical development teams as necessary to assure proper collection and reporting of clinical study adverse event data.<br/>* Verify data entered for clinical trial SAE and MESI reports into safety database.<br/>* Extracts records from EDC system, including query responses, for data entry into safety database.<br/>* Creates queries for missing information on clinical SAE reports.<br/>* Verify data entered for non-serious adverse events into safety database.<br/>* Communicate with Global Safety regarding the status of case analysis and the need for additional information relevant to the report.<br/>* 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.<br/>* Complete special projects as required.<br/>* Upon request, provide approved product safety related information e.g. product analysis to Health-Care professionals and patients.<br/>PHYSICAL REQUIREMENTS:<br/>* May be required to work company holidays and weekends.<br/>KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS<br/>* A Bachelor‘s Degree 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.<br/>* Exceptional knowledge of medical terminology and MedDRA coding.<br/>* Recent experience with MS Office products, particularly Excel, Word and Outlook.<br/><br/>Department CMR - PRODUCT SAFETY (1a)<br/>Position Location US - Princeton, NJ<br/>City Princeton<br/>State/Provinces US - NJ
<br/><br/>At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
<br/><br/>With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
<br/><br/><p class="eeo_desc">Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.<br/><br/>
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.<br/><br/>
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