Safety and Regulatory Affairs Officer Job at Novo Nordisk | Apply Now
A unique opportunity has arisen at Novo Nordisk for a Safety and Regulatory Affairs Officer in Dublin, Ireland. This role is pivotal for those with a strong background in pharmacovigilance and regulatory affairs, offering a chance to contribute significantly to patient safety and regulatory compliance.
Safety and Regulatory Affairs Job Details
- Position: Safety and Regulatory Affairs Officer
- Category: Reg Affairs & Safety Pharmacovigilance
- Location: Dublin, Leinster, IE
- 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.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 100 years of innovation and leadership in diabetes care. Headquartered in Denmark, the company has a strong presence in the pharmaceutical industry, focusing on chronic diseases such as diabetes, obesity, and hemophilia. With a commitment to sustainable growth and improving health outcomes, Novo Nordisk operates in over 80 countries and markets its products in more than 170 countries worldwide.
Safety and Regulatory Affairs Job Description
In this dual role, the Safety and Regulatory Affairs Officer will act as the Pharmacovigilance Responsible Person (PVRP) for Ireland while supporting regulatory affairs activities for Novo Nordisk medicinal products and medical devices on the Irish market. This position involves managing safety case processing, overseeing PV vendors, drafting Safety Data Exchange Agreements, leading regulatory submissions, and ensuring compliant labeling.
Eligibility Criteria
- 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, labeling requirements, and applicable legislation (including the IPHA Code).
- Strong project management, planning, prioritization, and organizational 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.
Safety and Regulatory Affairs Job – Key Responsibilities
- 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 minimization materials, and supporting the lifecycle management of product licenses with HQ and regional teams.
- Ensuring high-quality compliant labeling – 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.
This position at Novo Nordisk offers a significant opportunity for professionals in the field of safety and regulatory affairs to make a meaningful impact on patient safety and compliance. Interested candidates are encouraged to apply before the deadline.
Application Deadline: 6 September 2026
