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Manager, Quality

1 week ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
Manager, Quality & Compliance Monitoring, QPPV Office

Category: Reg Affairs & Safety Pharmacovigilance

Location: Søborg, Capital Region of Denmark, DK

Do you want to play a key role in driving the pharmacovigilance strategy and optimizing the Pharmacovigilance processes and activities? Would you like to be part of one of the most skilled and advanced pharmacovigilance (PV) functions in Denmark? Is setting direction and inspiring a team of highly engaged pharmacovigilance professionals your key competencies and/or passion?

If you find these challenges exciting, then you may be our new leader for the "Quality and Compliance Monitoring" team in the QPPV Office, Global Patient Safety, Denmark. Apply today for a life-changing career

The position
In this role, you will play a key role in driving the department strategy as well as executing action plans by leading a team of PV professionals, who are responsible for monitoring the performance of the PV System and ensuring high-quality safety data available to the organization by:

  1. Monitoring the quality of Individual Case Safety Reports (ICSRs) by establishing manual & automated quality control (QC) checks.
  2. Performing regular trend analysis to identify root causes for identified ICSR quality issues and improve processes to enhance case quality.
  3. Tracking ICSR timeliness compliance to internal and external submission deadlines and escalating any compliance issues to ensure appropriate remedial measures.

Strong collaboration with other departments within QPPV Office and Global Patient Safety, and our stakeholders in Affiliates and headquarters is essential for the role. You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional and inclusive collaboration, and international communication will be part of your workday. You can look forward to setting direction and providing guidance to the team and implementing continuous quality improvement projects.

Ensuring safe products and compliance with regulatory requirements is at the heart of Novo Nordisk's business. By being part of the QPPV Office you will play a crucial role in driving activities essential for our licence to operate.

Qualifications
To be successful in this position, you should have:

  1. A master's degree or PhD in Life Sciences such as Biomedical, Pharmaceutical or Medical Sciences or similar degree.
  2. 7+ years of experience in pharmacovigilance and/or within the value chain of the pharmaceutical industry with solid knowledge of PV and quality processes.
  3. Prior experience as a people or project manager, who can motivate, develop and empower professionals to achieve business goals.
  4. You are fluent in both written and spoken English.

As a person, you are enthusiastic, energetic, confident, and a strong team player. You can effectively prioritize for yourself and for the team, and cope well under pressure and navigate in uncertainty while maintaining direction and a healthy atmosphere for your team. You have demonstrated strategic planning skills and possess strong communication and presentation abilities. You work effectively in a highly matrix team structure and are capable of influencing cross-functional working groups.

About the department
QPPV Office is an area within Global Patient Safety, located in Novo Nordisk headquarters (HQ) in Denmark. Global Patient Safety is globally responsible for handling adverse events and monitoring patient safety in Novo Nordisk. QPPV Office consists of different departments responsible for various aspects of PV System oversight and support as well as performance monitoring.

The primary responsibilities of the Quality and Compliance Monitoring team are to provide support to Novo Nordisk's Qualified Person Responsible for Pharmacovigilance (QPPV) by monitoring PV system performance via key performance indicators related to ICSR quality and submission compliance. Furthermore, we help other HQ functions and affiliates across Novo Nordisk by providing PV advice and support on PV quality and compliance-related matters.

We use our diversity to generate novel ideas and create high-quality solutions leading to continuous improvement in PV processes to ensure optimal support to the Global Patient Safety and affiliates worldwide in safeguarding the patients using Novo Nordisk products.

Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop; we seize them. From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.

Contact
For further information, please contact Wasim Anwar at +45 3079 6766.

Deadline
16 March 2025.

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 the communities we operate in. Together, we're life-changing.

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