Post Marketing Surveillance (PMS) Specialist
Clinical, Medical, Regulatory
Seoul, Korea
Are you passionate about ensuring the highest standards of quality and compliance? Do you want to play a pivotal role in driving post-marketing surveillance activities? Join Novo Nordisk as a Post Marketing Surveillance Specialist and make a difference in the safety and efficacy of our products. Read more and apply today!
Your new role
As a Post Marketing Surveillance Specialist at Novo Nordisk, you will:
Responsible for planning and management of all regulatory post marketing surveillance (rPMS) activities in Korea, ensuring timely, budget-compliant execution and adherence to Helsinki Declaration, ICH- Good Clinical Practice (GCP) / Good Publication Practice (GPP), Novo Nordisk Standard Operating Procedures (SOPs) and applicable law. Lead PMS / Post-Authorisation Safety Study (PASS) projects in the country, driving project planning, conduct and coordination from protocol outline to study reporting and being accountable for timelines and deliverables. Ensure compliance and quality oversight across projects, including safety reporting, monitoring recruitment/reporting status, handling protocol deviations, co-monitoring visits, audits/inspections, and vendor (Contract Research Organization), CRO) activities. Manage budgets, filing and archiving in the Trial Master File, update clinical trial management systems (e.g., Cosmos), and support PMS assistant in contracts and negotiation of non-interventional study agreements. Identify and select sites, coordinate site assessments and recruitment efforts, collaborating with line manager to ensure appropriate staffing and site allocation. Provide PMS / PASS related communication and insight to key internal and external stakeholders, deliver project status updates, and contribute country input to key study documents. Coordinate organization support in collaboration with line manager and support any local audits/inspections.
Your new department
You will be part of the Clinical, Medical, Regulatory team based in Seoul, Korea. This department is dedicated to ensuring the highest standards of quality and compliance across all aspects of our operations. The team fosters a collaborative and dynamic atmosphere, where your expertise will contribute to the safety and efficacy of our products. Located in the vibrant city of Seoul, you will have the opportunity to work in a fast-paced environment alongside passionate professionals committed to making a difference.
Your skills & qualifications
We’re looking for a new PMS Specialist who will value working in a high-paced, dynamic environment. You’ll bring with you:
Minimum bachelor’s degree in medicine, Pharmacy, Nursing, Life Sciences or equivalent ICH GCP trained (and certified if applicable) with good knowledge of ICH GCP/GPP and clinical research principles At least 5–7 years’ relevant experience in PMS/PASS, clinical trials (CRA) and project lead/management, preferably including ~3 years as a project lead in a global pharmaceutical company Strong project and vendor (CRO) management skills with strategic thinking and cross-functional communication Fluent in written and spoken English and excellent IT skills (MS Word, Excel, PowerPoint)
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.
Deadline
Until the completion of recruitment. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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