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 PMS Project Lead and make a difference in the safety and efficacy of our products. Read more and apply today! Your new role As a Senior PMS Specialist, you'll take full ownership of regulatory post-marketing surveillance (rPMS) activities, ensuring compliance while delivering critical insights that enhance patient safety. You'll manage complex projects from conception to completion, coordinating across multiple stakeholders and ensuring every detail meets the highest standards. Depending on the seniority and the interview assessment of the candidate, the job title of this position may be changed to PMS Specialist, in case the level of experience is considered junior. Your responsibilities will include: <ul type="disc"> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Leading and managing PMS/PASS projects end-to-end, from protocol outline through to study reporting, ensuring all timelines and deliverables are met</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Ensuring strict compliance with Novo Nordisk policies, ICH-GCP/GPP, Helsinki Declaration, and all applicable Korean regulations</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Monitoring recruitment status and project quality, taking proactive action to address deviations and conducting co-monitoring visits when needed. Managing project budgets effectively and maintaining comprehensive documentation in Trial Master Files and clinical trial management systems</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Identifying, assessing and selecting appropriate sites for PMS/PASS projects in collaboration with your line manager and key stakeholders; Maintaining timely communication with Health Authorities and IRB/Ethics Committees, providing all required documentation and updates</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Coordinating vendor relationships and CRO activities, ensuring quality oversight across all external partnerships</li> </ul> Your new department The Post Marketing Surveillance (PMS) Team in Korea is responsible for planning and management of all regulatory post-marketing surveillance activities in a timely and effective manner, within budget and complying with regulatory requirements. Our work ensures that once our medicines reach patients, we continue to monitor their safety and effectiveness, providing crucial real-world evidence that shapes treatment approaches. Your skills & qualifications We're looking for an experienced PMS professional who thrives in a regulated environment and brings both strategic thinking and operational excellence. You should have: <ul type="disc"> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Minimum Bachelor's degree in Medicine, Pharmacy, Nursing, Life Sciences or equivalent (preferred)</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">At least 5 years of working experience in PMS/PASS (minimum 5 years mandatory), with clinical trial experience as a CRA and project lead/manager preferred. ICH GCP training and certification (if applicable) will be added advantages.</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Preferably 3 years of experience as a project lead in a global pharmaceutical company, with strong project management skills including vendor (CRO) management with strategic thinking capability</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Excellent cross-functional communication skills to engage effectively with internal teams, external vendors, regulatory authorities and clinical sites</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Fluency in written and spoken English and excellent IT skills including MS Office Package (Word, Excel and PowerPoint)</li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt;color:black">Good knowledge of ICH GCP/GPP and clinical research practices</li> </ul> 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 are reviewed on an ongoing basis, and the posting might be closed earlier than planned so you are strongly 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.

Senior Post Marketing Surveillance (PMS) Specialist (Seoul, Seoul, KR) @ novonord

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