Location: Plainsboro,NJ, USA
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
As North America responsible person, the head of Patient Safety will act as the safety expert to establish and maintain processes, procedures and controls to ensure compliance with all relevant internal and external requirements and regulations relating to technical complaints, adverse events and other safety information in the US and Canada. Overall responsible for compliance with US drug and device safety reporting regulations, Health Canada regulations ICH guidelines and the management of contracts with safety reporting requirements. Key contact person for FDA and Health Canada PV inspections and device inspections as well as key contact for all safety related communications with the authorities. Responsible for providing long term strategic vision, expertise, leadership and direction for Patient Safety for North America Operations (NAO); as well as significantly contributing to the strategic vision of Clinical Medical Regulatory (CMR) Strategic Operations. Overall responsible for activities related to the maintenance of the safety profile of the company's products (e.g. Local Labelling Committee, Promotional Review Board) in close collaboration with Headquarters (HQ), Novo Nordisk, Inc. (NNI) and Novo Nordisk Canada, Inc. (NNCI).
Relationships
This position reports directly to the Vice President, CMR Strategic Operations.
External relationships include regulatory authorities: FDA and Health Canada AE and MDR and relevant vendors.
Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI Patient Support Solutions.
Essential Functions
* Accountability:
* Will serve to represent the Patient Safety department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required
* Timely completion of Patient Safety Assessment activities through product development, product maintenance and lifecycle management
* Ensure Signal Management processes and activities are compliant with NAO regulations and NAO regulatory authority and inspectors' expectations; Ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guideline
* Ensure that signal detection, evaluation and management processes meet highest standards by working cross functionally and managing the oversight of all required processes
* Designs and promotes systems to continuously improve business productivity within and across departments in relation to department and company goals and objectives
* Stakeholder Engagement:
* Build strong relationships with the cross functional teams, to influence and ensure that the development-, regulatory and or medical strategy and procedures are aligned with the safety strategy as well as with company objectives
* Liase with Patient Support Solutionsto ensure compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs)
* Compliance With FDA and Health Canada Reporting Regulations & Audits:
* Drive preparedness for regulatory authority inspection and internal audits for PV operational activities for NAO; participate in audits/inspections as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/inspection preparedness and participation
* Serves as NAO's Lead regarding FDA and Health Canada safety reporting responsibilities
* Directs the safety department activities to ensure FDA and Health Canada safety submissions as required
* Directs the development of SOPs at NNI and NNCI documenting compliance with corporate policies and local safety needs
* Product Quality:
* Oversees the implementation of procedures to ensure compliance with Good Manufacturing Practice (GMP) with respect to technical complaint handling at NNI and NNCI
* Risk-Based Data Insights:
* Responsible for the creation of KPIs for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters
* Strategize and align with the key stakeholders in developing data collection/processing strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategies
* Experience with safety data collection and interpretation originating from clinical trials and other sources
* Strategic Oversight:
* Provides effective and timely safety updates to management on matters concerning safety promotional review, safety labelling committee input, safety data analysis and contract review and vendor management for vendors handling safety information
* Leadership:
* Provides strong people management of the Patient Safety leadership team across NNI, GBS, and NNCI including teambuilding, motivating, empowering and developing people
* Changing Regulatory Landscape:
* Maintains up-to-date knowledge of the regulations and guidelines issued by the FDA and Health Canada along with other industry periodicals impacting safety reporting issues
* Attends PV industry meetings
Physical Requirements
10-20% overnight travel required.
Development Of People
Supervisory role. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
* Bachelor's degree required in health sciences or other relevant health-related field; Advanced degree preferred (e.g. MD, PhD, PharmD, NP)
* A minimum of 10 years of relevant experience in drug safety/pharmacovigilance, or related fields required
* Minimum of 6 years of people management experience required, and experience in mentoring others
* In-depth knowledge of North America (US, CA), EU drug safety regulations, CIOMS and ICH guidelines required
* Proven track records of strategic decision-making and leadership skills
* Experience with Signal Detection and Pharmacovigilance databases i.e. Argus, Cognos, Empirica, etc.
* Excellent communication skills with clear ability to impact and influence without authority
* Demonstrated ability to work in a matrix environment and to influence key stakeholders as it relates to innovative safety science and pharmacovigilance
* Strong collaboration skills with enterprise mindset
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-###-####. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.