Novo Nordisk

Post Marketing Surveillance Specialist

Novo Nordisk

full-time

Posted on:

Location Type: Office

Location: Seoul • South Korea

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Tech Stack

Google Cloud Platform

About the role

  • 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.

Requirements

  • 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).
Benefits
  • None specified 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory post marketing surveillancePost-Authorisation Safety Studysafety reportingclinical trial managementproject managementprotocol developmentbudget managementclinical researchvendor managementsite assessment
Soft Skills
strategic thinkingcross-functional communicationproject leadershipcollaborationstakeholder communicationquality oversighttimelinessproblem-solvingorganizational skillsnegotiation
Certifications
ICH GCP certification