Safety and Regulatory Affairs Officer

 Safety and Regulatory Affairs Officer 

 
Dublin, Ireland 

Take ownership as the Pharmacovigilance Responsible Person for our Irish affiliate and lead regulatory projects that keep life-changing medicines safe, compliant and available to the patients who rely on them. If you thrive at the intersection of science, regulation and patient safety, this is your opportunity to make a tangible difference. 

Your new role 

 
In this dual role, you will act as our Pharmacovigilance Responsible Person (PVRP) for Ireland while supporting regulatory affairs activities for Novo Nordisk medicinal products and medical devices on the Irish market. 

Day-to-day your tasks will include: 

• Managing safety case processing, triage, follow-up and expedited reporting (ICSRs, SUSARs, medical device reports, DMC statements) to Global Patient Safety and Customer Complaints, in line with regulations and internal Novo Nordisk requirements 

• Overseeing PV vendors, reconciliation and QC processes, and maintaining systems such as Veeva Safety, Vault Quality, IO-CCS and HALO PV for Ireland 

• Drafting and maintaining Safety Data Exchange Agreements (SDEAs), conducting PV training for employees and vendors, and monitoring the safety mailbox and Irish medical journals for reportable information 

• Leading regulatory submissions, variations, renewals, PSURs and risk minimisation materials, and supporting the lifecycle management of product licences with HQ and regional teams 

• Ensuring high-quality compliant labelling – including SmPCs, PILs and Abbreviated Prescribing Information – and keeping VaultRIM and regulatory trackers up to date 

• Interfacing and negotiating with external stakeholders such as HPRA, HSE and IPHA, and providing accurate regulatory advice to internal business units 

• Supporting activities related to non-compliances, deviations, change requests, stock shortages, parallel trade notifications and audit/inspection readiness 

Your new department 

 
As part of International Operations, you will join our largest operational unit. Covering 194 countries and 95% of the world's population, more than 18,000 of us work passionately to serve 35 million patients each day. With a promise to outperform the competition, we continue to be the growth driver for Novo Nordisk, and to improve health at scale across the globe. 

You will join the Regulatory & Safety team within our Irish affiliate, working closely with colleagues across medical, commercial and customer service, as well as with Headquarters (NN A/S) and regional counterparts. It is a role with real breadth – combining hands-on operational responsibility with strategic influence on how Novo Nordisk products are launched, maintained and communicated in Ireland. 

Your skills & qualifications 

 
We are looking for a detail-oriented professional who enjoys working across disciplines and takes pride in getting the compliance details right. You will bring with you: 

• A 3rd level qualification, preferably a graduate degree in Life Sciences 

• Relevant industry experience, preferably within pharmacovigilance and/or regulatory affairs, ideally combined with proven success in an ethical pharmaceutical customer-facing role 

• Solid knowledge of pharmacovigilance systems, regulatory approval processes, labelling requirements and applicable legislation (including the IPHA Code) 

• Strong project management, planning, prioritisation and organisational skills, with a clear concern for quality and detail 

• Excellent written and verbal communication skills in English, with the confidence to influence internal stakeholders and negotiate with external authorities such as HPRA, HSE and IPHA 

• A collaborative, solutions-focused mindset – comfortable embracing change, making decisions and delivering results in a regulated environment 

Working at Novo Nordisk 

 
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations. 

What we offer 

 
Salary: For this role, the Annual Base Salary ranges from  €62,560 – €100,090 corresponding to Job Level 6 and the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.    

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.  

Learn more about our Reward Philosophy here. 

Deadline 

 
6 September 2026. Applications are reviewed on an ongoing basis, so please apply as soon as possible.