Patient Safety Associate

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Patient Safety Associate

Facility: Reg Affairs & Safety Pharmacovigilance Location: Plainsboro, NJ, US About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference? The Position Responsible for the receipt, documentation and triage of safety information, including adverse events and technical complaints for Novo Nordisk Inc. (NNI) US marketed products (drugs and devices). Responsible for ensuring compliance is met with all internal and external (e.g. FDA) drug and device safety reporting regulations. Relationships Reports to Patient Safety Management. Daily internal interactions with personnel from Patient Safety, Medical Information, Field Sales, Customer Complaints Center, Suppliers and Patient Centric Customer Care. Daily external interactions with patients, caregivers, and health-care professionals. Essential Functions

• Collect and document information received from inbound and outbound contacts (verbal and written communications) from and to healthcare professionals, NNI sales personnel, patients, caregivers and vendors related to adverse events and technical complaints associated with NNI products
• Identification of adverse events and event seriousness, causality and case classification (solicited vs. spontaneous, device vs. drug)
• Perform triage and data entry of adverse events with or without associated technical complaints and other safety information into applicable databases
• Facilitate customer replacements and refunds;
• Generation and handling of follow-up letters
• Scan and archive incoming mail containing safety information
• Process feedback from Customer Complaint Center and Clayton; provide feedback to case handlers
• Handle inbound and outbound calls for adverse events with or without associated technical complaints, replacements, and/or refunds, as applicable
• Generation of investigation result letters for patients and healthcare professionals who report product quality issues
• Support audits/inspections as needed
• Build customer loyalty by providing high quality customer service
• Provide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scripts
• Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management
• Assist with department related projects

Physical Requirements 0-10% overnight travel required; Hybrid schedule of 2 days in NJ office and 3 days remote; May require occasional work outside of standard business hours to support special requests/events. Qualifications

• Bachelors degree required, preferably in science or healthcare discipline; relevant experience may be substituted for degree, when appropriate (e.g. Registered Nurse with clinical experience)
• A minimum of 1-year Patient Safety experience preferred
• Strong knowledge of medical and pharmacovigilance terminology required
• MedDRA coding and adverse event identification experience preferred
• Knowledge of NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders)
• Experience with audits/inspections preferred
• Analytical thinking skills required
• Proficiency in Windows, Microsoft Word, Excel and Outlook required
• Experience with a Call Center and Drug Safety database preferred
• Strong oral and written communication skills required
• Ability to work with sensitive or confidential information required
• Strong attention to detail required
• Ability to handle multiple priorities and demands in a fast-paced environment required
• Strong planning, organizational and time management skills required
• Ability to interact with various levels of the organization required
• Ability to form strong working relationships with stakeholders required
• Bi-lingual (Spanish-English) a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.