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Manager - Contract Review and Compliance Reporting
4 months ago
**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**
To ensure oversight and management of all contract and vendor related activities in Patient Safety including, but not limited to, contract review and vendor management support in regards to safety reporting.
To serves as a liaison between NNI Patient Safety Group and other departments on Safety Data Exchange Agreement (SDEA) related matters.
To contribute and support quality monitoring activities related to Adverse Event reporting and quality tasks performed by suppliers and business partners to ensure compliance with SDEA requirements.
**Relationships**
This position reports to the Director, Case Review & Compliance Reporting within Patient Safety. This position works closely with including, but not limited to the following: all units in Patient Safety, NNI GXP Support, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP Auditor(s) as well as with counterparts in Global Safety and Contract Owners in NNAS. External relationships include interactions with NNI business partners, suppliers, healthcare professionals and with FDA personnel concerning Patient Safety reporting matters related to contracts and SDEA 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 goals
- Manages Patient Safety’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 SDEA requirements, and supplier relations
- Oversees safety data reconciliation and QC activities from suppliers and corporate partners to ensure compliance with SDEA requirements
- Supports development and maintenance of Pharmacovigilance System Master File (PSMF). Ensures accuracy and completeness of data collection programs and associated SDEAs in the Global Safety PV Oversight System
- Monitors and manages the Patient Safety Contracts Management mailbox. Assigns and delegates tasks as appropriate
- Understands Patient Safety case processing and NNI contracting operations including tool and systems used, exceptions processes, and workflows
- Collaborates with all units within Patient Safety, other business areas at NNI, GBS and Global 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 appropriate
- Supports internal and external training activities related to contract and vendor management
- Provides guidance to contract owners and other stakeholders on safety reporting requirements, incl. Safety Data Exchange Agreements
- Contributes to business continuity and resource planning. Ensures adequate coverage for essential tasks at all times
- Provides strategic input and contributes to process / quality improvement initiatives
- Guides the successful completion of major programs or initiatives, and may function in a project leadership role
- Regulatory compliance:
- Ensures compliance with all Federal regulations, guidance, and company SOPs regarding adverse event reporting from post-marketing sources and clinical trials complaint handling
- Ensures local/affiliate SDEA templates meet both Global and local regulatory requirements
- Supports audit and inspection readiness
- Develops and maintains company (safety) SOPs
- Business partner liaison:
- Liaises with suppliers and corporate partners on safety reporting and monitoring issues as appropriate
- Serves as primary contact, facilitator and communicator of information to other departments within NNI and NNAS concerning contracts, vendors and SDEA 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 healt
