What are the responsibilities and job description for the Director of Pharmacovigilance position at Novo Nordisk?
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
As Director of Pharmacovigilance, Boston Global Development, you will manage the local pharmacovigilance team and be accountable for the oversight and development of the safety strategy and major safety deliverables for 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.
Relationships
This position reports directly to the Vice President of Submission Lifecycle Management, Boston Global Development and will have a dotted reporting line into the larger Global Safety Surveillance Department in Denmark. As a local leader, the Director of Pharmacovigilance is expected to drive initiatives to improve working procedures, quality, and development of staff.
Essential Functions
- Lead the Pharmacovigilance team for Boston Global Development and effectively manage the team in accordance with the Novo Nordisk (NN) Way, the Global Leadership Competency Framework, and other applicable NN procedures
- Lead/oversee the establishment of the product safety profile throughout development and support generation of associated documentation for key internal and external stakeholders, including but not limited to, NN management, regulatory authorities, ethics committees, investigators/health care providers, and patients
- Lead/oversee safety surveillance of products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety information internally and to regulatory authorities
- Chair/oversee NN cross-functional safety committees for programs within Boston Global Development’s portfolio, including leading/overseeing establishment of the safety committee and execution of meetings
- Responsible for all areas related to patient safety in clinical trials
- Ensure adequate safety representation in cross functional project teams (e.g., Global Project Team, Medical Science Team, Clinical Team Meetings)
- Responsible for safety input to all activities for Risk Based Monitoring across Boston Global Development’s portfolio
- Develop direct reports to improve their current performance and future potential through coaching and development opportunities utilizing performance management systems and individual development plans along with frequent interactions
- Provide timely and accurate input to the local departmental budget
- Support and enable knowledge sharing and capability building across teams, projects, sites, and skill areas
Physical Requirements
Approximately 10% overnight travel required.
Development of People
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
- MD or PhD with 8-11 years relevant experience or Master’s with 12-14 years relevant experience
- Strong experience with cross functional teamwork and demonstrated talent for leadership
- Experience managing others
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.
Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.
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.
