Post Marketing Surveillance Specialist
1주일전에
Are you passionate about ensuring the quality and safety of pharmaceutical products? Do you have experience in post marketing surveillance and project management? If so, you might be the perfect fit for our team Read more and apply today for a life-changing career.
About the department
You will be part of a global healthcare company with 100 years of innovation and leadership in diabetes care. Headquartered in Denmark, Novo Nordisk employs over 60,000 people in 80 countries and markets its products in more than 170 countries. Our department is dedicated to fostering a collaborative and innovative atmosphere where every team member can make a significant impact.
Novo Nordisk has been globally recognized as the Best Place to Work, topping the ranks for two consecutive years in 2022 and 2023. It is an exciting time to join Novo Nordisk and be part of a dynamic company in an even more dynamic industry, helping us achieve our aspirations to establish a global presence in the industry.
The position
PMS Specialist is responsible for planning and management of all regulatory post marketing surveillance (rPMS) activities in Korea in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki Declaration, ICH-GCP/GPP (Good Pharmacoepidemiology Practice) and NN SOPs (Standard Operating Procedures)
As a PMS Specialist at Novo Nordisk, you will:
- The role involves leading and managing Post Marketing Surveillance (PMS)/Post Authorization Safety Study (PASS) projects in the country, overseeing all aspects from planning to execution and reporting. Key responsibilities include ensuring compliance with Novo Nordisk policies, ICH-GCP/GPP, and relevant regulations, managing project timelines and deliverables, and monitoring recruitment and reporting status. The role also requires reviewing and following up on monitoring visit reports, ensuring safety reporting requirements are met, overseeing the quality of project execution, managing budgets, and maintaining proper documentation. Additionally, responsibilities include negotiating contracts with vendors and sites, coordinating site assessments, and collaborating with the line manager to ensure effective site recruitment and staffing.
- This role also involves managing communication related to PMS/PASS projects with internal and external stakeholders. Responsibilities include providing project updates to the line manager, offering vendors and clients timely status reports, and delivering consolidated country input for key study documents (e.g., protocol, ICF). The role also involves maintaining communication with Health Authorities (HA) and Ethics Committees (IRB/EC), ensuring they receive requested documents, and supporting audits or inspections of the local organization. Additionally, the role ensures effective communication of PMS/PASS issues between HQ, regions, and affiliates.
- Coordinate organization support in collaboration with line manager
- Is expected to have a strong ability to make independent decisions in relation to project management and site management and in accordance to the framework of functional responsibilities, training and advice to junior colleagues and at investigator sites. Issues management and escalation of non-compliance in a timely and as appropriate.
- Proactively seek for continuous improvements through innovations and initiatives within assigned tasks are encouraged. Such should always be demonstrated when analyzing, prioritizing, planning and performing tasks either assigned by management or initiated by oneself. This should be approved by line manager and should always perform in compliance with Novo Nordisk Policies and Novo Nordisk Fundamentals.
Qualifications
- Minimum bachelor’s degree in medicine, Pharmacy, Nursing, Life Sciences or equivalent is preferred.
- ICH GCP trained and if applicable, certified as well as good knowledge of ICH GCP / GPP and another clinical research.
- At least 7 years of working experience in clinical trials, PMS/PASS as a CRA and project manager is preferred. Preferably, candidates with 3 years of experience as a project lead in a global pharmaceutical company.
- Good communication skill with project management skill (including vendor (CRO) management) as well as strategic thinking, excellent IT skill including MS office Package (Word, Excel and PowerPoint)
- Fluent in written and spoken English.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
Upload your CV to our online career page (click on Apply and follow the instructions).
Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
#LI-AMS1
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