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    Patient Safety Associate

    Novo Nordisk
    0-2 years
    Not Disclosed
    Plainsboro
    10 Nov. 11, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Patient Safety Associate

    Location: US (Novo Nordisk Inc.)
    Department: Clinical, Medical, and Regulatory (CMR)

    Are you passionate about patient safety and quality service?

    Join Novo Nordisk in a role where you can contribute to the safety and well-being of patients using our products. As a Patient Safety Associate, you will play a critical role in collecting, documenting, and triaging safety information for our marketed drugs and devices. If you’re looking to make a real difference in people’s lives, this is the opportunity for you.

    The Position

    As a Patient Safety Associate, you will be responsible for the receipt, documentation, and triage of adverse events and technical complaints related to Novo Nordisk Inc. (NNI) US marketed products, ensuring full compliance with both internal and external regulations, such as those set by the FDA. You will work with a variety of stakeholders, including healthcare professionals, patients, and vendors, to ensure timely and accurate safety reporting.

    Your key responsibilities will include:

    • Safety Information Management: Collect and document adverse event information from inbound and outbound communications (e.g., from healthcare professionals, patients, caregivers, and vendors).
    • Event Classification and Triage: Identify and assess adverse events, determining their seriousness, causality, and classification (e.g., solicited vs. spontaneous, device vs. drug).
    • Database Management: Enter safety data into the relevant databases, ensuring accurate and complete reporting.
    • Customer Service: Handle inbound and outbound calls related to adverse events, technical complaints, and product quality issues, providing high-quality customer service and facilitating replacements or refunds where necessary.
    • Follow-up and Communication: Generate follow-up letters and investigation result letters, addressing product quality issues with healthcare professionals and patients.
    • Process Improvement: Identify procedural deficiencies and recommend improvements to enhance efficiency and safety processes.
    • Audit/Inspection Support: Assist with audits and regulatory inspections as required.

    Qualifications

    To succeed in this role, we are looking for candidates with:

    • A Bachelor’s degree in a science or healthcare-related field, or relevant experience (e.g., a Registered Nurse with clinical experience).
    • Minimum 1 year of experience in Patient Safety or Customer Service (preferred).
    • Knowledge of medical and pharmacovigilance terminology.
    • Experience with MedDRA coding and adverse event identification is preferred.
    • Familiarity with Novo Nordisk-supported disease states (e.g., diabetes, obesity, hemophilia, growth hormone disorders) is a plus.
    • Proficiency in Microsoft Office (Word, Excel, Outlook).
    • Ability to work with sensitive and confidential information.
    • Strong communication skills, attention to detail, and the ability to multitask in a fast-paced environment.
    • Bilingual (Spanish-English) is a plus.

    About the Department

    The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is a dynamic and collaborative team, focused on patient-centered care. From developing regulatory strategies with the FDA to providing medical education and collecting data to support product efficacy, CMR drives the success of Novo Nordisk’s innovative products. As a member of this team, you will contribute directly to improving the quality of life for patients around the world.

    Working at Novo Nordisk

    At Novo Nordisk, we value our employees and are committed to creating an inclusive work environment where diverse perspectives, backgrounds, and cultures are celebrated. We understand the importance of work-life balance and strive to provide meaningful career opportunities where employees can grow and thrive. Join us to be part of a company that’s dedicated to changing lives.

    How to Apply

    If you are ready to join a life-changing career, apply now! Please submit your CV and include a few sentences explaining why you are applying for the position. Cover letters are not required, and we kindly ask that you do not include a photo in your CV for an efficient recruitment process.

    Deadline

    Applications will be reviewed on an ongoing basis.

    Equal Opportunity Employer

    Novo Nordisk is an equal opportunity employer. We value diversity and encourage applicants from all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

    Contact

    If you need assistance or an accommodation to apply, please contact us at 1-855-411-5290. This number is for accommodation requests only.

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