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Job Description
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 healthcare 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 To ensure oversight and management of all contract and vendor related activities pertaining to Patient Safety including but not limited to contract review and vendor management support in regard to safety information reporting. To serve as a liaison between USO PS & GxP
BUSINESS OPS, USO
Patient Safety Group and other departments on Pharmacovigilance Agreement (PVA) related matters. To contribute and support quality monitoring activities related to safety information reporting and quality tasks performed by suppliers and business partners to ensure compliance with PVA requirements. Relationships This position reports to the Associate Director or Director, Patient Safety Vendor Management. This position works closely with including but not limited to the following: all units in Patient Safety, USO QA, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services Bangalore (GBS-BLR), PV & GDP Auditor(s) as well as with counterparts in Global Patient Safety and Contract Owners in NNAS. External relationships include interactions with NNI business partners, suppliers, healthcare professionals and with FDA personnel concerning safety information reporting matters related to contracts and PVA requirements.
Essential Functions Administration:
Exercises considerable latitude and applies extensive pharmacovigilance knowledge and technical expertise in determining and implementing strategies consistent with the unit's functional and corporate goalsManages Patient Safety Vendor Management's responsibilities and maintains oversight toward Patient Support Programs (PSP), Market Research Programs (MRP), call centers, digital health initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, management of PVA requirements, and supplier relationsOversees safety information reconciliation and QC activities from suppliers and corporate partners to ensure compliance with PVA requirementsSupports development and maintenance of Pharmacovigilance System Master File (PSMF). Ensures accuracy and completeness of data collection programs and associated PVAs in the Global Patient Safety PV Oversight SystemMonitors and manages the Patient Safety Contracts Management mailbox. Assigns and delegates tasks as appropriateUnderstands Patient Safety case processing and NNI contracting operations including tool and systems used, exceptions processes, and workflowsCollaborates with all units within Patient Safety, other business areas at NNI, GBS-BLR and Global Patient Safety to ensure late reports from suppliers and business partners have been correctly identified and documented as per relevant SOPs and reported to management. Perform proper root cause analysis, identification, documentation, correction, corrective and preventive action, as appropriateSupports internal and external training activities related to contract and vendor managementProvides guidance to contract owners and other stakeholders on safety reporting requirements, incl. PVAsContributes to business continuity and resource planning. Ensures adequate coverage for essential tasks at all timesProvides strategic input and contributes to process / quality improvement initiativesGuides the successful completion of major programs or initiatives, and may function in a project leadership roleParticipates in onboarding and training of new Patient Safety Vendor Management staff and contingency workers
Regulatory Compliance:
Ensures compliance with all Federal regulations, guidance, and company SOPs regarding safety information reporting from post-marketing sources and clinical trials complaint handlingEnsures local/affiliate PVA templates meet both Global and local regulatory requirementsProvides audit and inspection readiness and supportDevelops and maintains company (pharmacovigilance) SOPsMaintains up to date knowledge of the regulations and guidelines issued by
FDA and ICHBusiness Partner Liaison:
Liaises with suppliers and corporate partners on safety reporting and monitoring issues as appropriateServes as primary contact, facilitator and communicator of information to other departments within NNI and NNAS concerning contracts, vendors and PVA requirements related matters Physical Requirements 0-10% overnight travel required. Qualifications A Bachelor's Degree in medical or life science area with a minimum of 8 years' relevant experience required; or a healthcare professional (HCP e.g. RN or R.Ph) with a minimum of 5 years' experience, including 3 years in safety reporting. Advanced degree preferredExcellent organizational skills with high attention to detailExcellent project management skills, with ability to manage multiple priorities and move projects forward while maintaining high quality and meeting deadlinesExcellent oral and written communication skillsIntermediate proficiency in Windows, MS Word, PowerPoint and Excel requiredKnowledge of FDA requirements in safety information reporting and GMP regulationsPrevious pharmaceutical industry experience in contract or alliance management preferred The base compensation range for this position is $120K to $171K. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. 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.
