Safety Surveillance Lead

About the Department

The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference?

The Position

We are seeking a collaborative and science-driven global pharmacovigilance expert who wants to work with innovative investigational medicines. As Safety Surveillance Lead, Boston Global Development, you will be accountable for the oversight and development of the safety strategy and major safety deliverables for assigned programs within the Boston Global Development portfolio in close collaboration with others from the Global Safety Surveillance Department. This will include managing the cross-functional assessment of benefit-risk profiles and communication of safety information to internal and external stakeholders.

It will be your job to:

• Ensure thorough safety contributions to the clinical and regulatory strategies for assigned products
• Ensure the safety profile for assigned products is carefully monitored and appropriate actions are taken, as needed, to minimize risk for patients
• Lead the internal Novo Nordisk safety committees for assigned products

This means that building relationships with important stakeholders and being able to collaborate across sites and with colleagues across the Global Safety Surveillance Department is crucial for success. You will maintain state of the art competences and know-how within the field of pharmacovigilance.

Relationships

The position will report to Senior Director, Pharmacovigilance.

Essential Functions

• Serves as the process expert for signal management for assigned programs
• Handles process changes and deviations in Safety Surveillance in close collaboration with relevant colleagues
• Responsible for the establishment of the product safety profile during development and maintenance of the labelling for marketed products
• Conducts safety surveillance of Novo Nordisk products during pre-approval and post-approval phases based on safety information from worldwide sources and communicates drug safety issues internally and to health authorities, as required
• Chairs/attends NN cross-functional safety committees, including establishment of the safety committee and execution of meetings
• Responsible for all areas related to patient safety in clinical trials
• Is the safety representative to cross functional project teams, which may include Clinical Study Teams, the Medical Science Team, and Global Project Team, for assigned programs
• Is responsible for safety input to all activities for risk based monitoring across assigned development projects

Physical Requirements

Approximately 10% overnight travel required.

Qualifications

• PhD with 4-5 years relevant experience, Masters with 6-8 years relevant, experience, Bachelor with 10+ years relevant experience, or equivalent knowledge through relevant practical experience
• Excellent verbal and written communication skills
• Strong organizational and demonstrated problem-solving capabilities, and
• Ability to thrive in a busy environment and maintain a positive attitude under pressure

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.