Local Qualified Person for Pharmacovigilance & Regulatory Backup

Are you an experienced professional in Pharmacovigilance and Regulatory Affairs? Are you looking for a new challenge in a dynamic and fast-paced environment? Novo Nordisk is seeking a Local Qualified Person for Pharmacovigilance (local QPPV) and Regulatory Backup to join our team. If you are passionate about ensuring the safety and compliance of medicinal products and medical devices, then this could be the perfect opportunity for you.

This position will be based in in Zagreb, Croatia under the Clinical, Medical, Regulatory and Quality (CMRQ) department.

Read on and apply today for a life-changing career!

The Position

As a Local Qualified Person for Pharmacovigilance (local QPPV) and Regulatory Backup, you will manage local Pharmacovigilance (PV) activities and ensure compliance with local regulations and processes.

Your main accountabilities will be:

• Act as Local Qualified Person for Pharmacovigilance (local QPPV) and maintain contact with local Drug Agency, health authorities, and NN Global Service in relation to the safety of Novo Nordisk’s (NN) products
• Complete registration plans and launch plans for new products, ensuring updated regulatory information and submission systems
• Ensure updated local labelling and compliance with all legal requirements from a regulatory affair perspective
• Provide PV trainings to NN Croatia Ltd employees to ensure the proper functioning of the PV system and secure patient safety
• Support internal customers in relation to regulatory issues. Interact with healthcare/regulatory authorities regarding NN product registrations or related issues. Represent NN vision, values, and commitments in daily interactions with customers.

Qualifications

As a Local Qualified Person for Pharmacovigilance (local QPPV) and Regulatory Backup, you need to have University degree as Medical doctor/Veterinarian/Dentist, or Master/Doctor of Pharmacy or Medical biochemistry. Moreover, you need to have minimum 2 years of experience in pharmacovigilance allowing to immediately take over the role of local QPPV.

To be successful in this role you should have:

• Knowledge and experience in a similar position within Pharmacovigilance and Regulatory Affairs
• Fluent in written and spoken English.
• Strong time management and self-organization skills.
• Ability to take responsibility and work independently with high accuracy.

About the Department .

The Clinical, Medical, Regulatory and Quality department (CMRQ) at Novo Nordisk play crucial roles in the development, approval, and post-approval activities of the company's medicinal products as well as ensuring high quality standards with all our products and processes. Novo Nordisk started in Croatia in 1991, the affiliate is part of the Business Area South East Europe (BASEE) in the Region South East Europe, Middle East & Africa (SEEMEA). We are a dedicated team of 40 people based in Bundek Centar in Zagreb.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

Please click on "apply now" to submit your resume in English before 23rd of July, 2024

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.