Senior Pharmacovigilance Specialist

Are you highly motivated by being able to make a difference in improving patients’ lives? Are you a high-performing executive who is energized by challenges and able to influence people around you? If so, you should continue reading and apply today!

In Novo Nordisk Korea, the position of (Sr.) Pharmacovigilance (PV) Specialist provides you the opportunity to work in a high-performing team to contribute directly towards the business results while creating values.

About the department
Novo Nordisk is a global healthcare company with more than 100 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 63,000 people in 80 countries and markets its products in more than 170 countries.

The position

This position has been newly created as part of the team expansion and will report directly to the PV Manager.

The job title of this position will be either PV Specialist or Sr. PV Specialist depending on the experience level of the candidate. This position is permanent.

As a Senior PV Specialist, you are responsible for supporting the maintenance of the compliance and quality of the affiliate pharmacovigilance system. You will timely update the PV oversight system with local requirements for Pharmacovigilance System Master File (PSMF) by conducting gap analysis and updating relevant PV Standard Operating Procedures (SOPs). You will also lead the management of the Risk Management Plan (RMP) of dedicated products with relevant stakeholders as required by relevant regulations and internal SOPs. You will timely update the PV oversight system with local requirements for Pharmacovigilance System Master File (PSMF) by conducting gap analysis and updating relevant PV Standard Operating Procedures (SOPs) and quality checks of customer contacts according to Novo Nordisk (NN) procedures.

Main accountabilities are as follows, but are not limited to:

• Ensure reporting of safety information from spontaneous and solicited sources of marketed products and clinical trials to Global Safety (GS) and Health Authority (HA) in accordance with local regulation and NN procedures. Conduct the quality check on the cases reported by PV associate and PV assistant. Oversee and supervise safety information reporting conducted by the business partners and service vendors.
• Handle safety information reported by Novo Nordisk personnel and distribute Individual Case Safety Report (ICSRs) and aggregate safety reports to Korea Clinical Development Center and report to HA, if needed.
• Prepare PV audits and HA inspections. Manage internal projects with Global Safety or region PV.
• Prepare and lead the management of the Risk Management Plan (RMP) with relevant stakeholders as required by relevant regulations. Provide training regarding pharmacovigilance to internal & external stakeholders and manage Safety Data Exchange Agreement (SDEA).
• In the absence of local Qualified Person for Pharmacovigilance (QPPV), back-up the activities as per the duration.

Qualifications

• You hold a bachelor’s degree in Pharmacy, Life Science, Nursing or a related scientific field.
• Pharmacist is highly preferred. 
• At least 5 years of relevant experience in Pharmacovigilance is preferred.
• Proficiency in both speaking and writing in English and local Korean language is essential.

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 energise 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
Kindly upload your CV to our online career page (click on Apply and follow the instructions). 

Internal candidates are requested to inform their Line Manager when applying.  
 

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.

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