- 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
- 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 preferred
- Excellent organizational skills with high attention to detail
- Excellent project management skills, with ability to manage multiple priorities and move projects forward while maintaining high quality and meeting deadlines
- Excellent oral and written communication skills
- Intermediate proficiency in Windows, MS Word, PowerPoint and Excel required
- Knowledge of FDA requirements in safety reporting and GMP regulations
- Previous pharmaceutical industry experience in contract or alliance management preferred
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Manager - Contract Review and Compliance Reporting - Plainsboro, United States - Novo Nordisk
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 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
Physical Requirements
0-10% overnight travel required.
Qualifications
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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
