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Pharmacovigilance Associate (Safety Professional)

Category:  Clinical Development and Medical
Location: 

Seoul, Seoul, KR

Are you highly motivated by being able to make a difference to improving patients’ lives?

 

Are you a high performing executive who energized by challenges and able to energize people around you? If so, you should continue reading …

 

Location

 

This job is based in Seoul Metropolitan area.

 

Purpose of the Job

 

Responsible to ensure reporting safety cases to Global Safety and Health Authority in accordance with local regulation and internal procedures, and assist to maintain the compliance and quality of affiliate pharmacovigilance system 

 

Main accountabilities

 

1. Ensure to report safety information from spontaneous and solicited source of marketed products, clinical trials, to Global Safety(GS) and Health Authority(HA) in accordance with local regulation and Novo Nordisk(NN) procedures

• Closely monitor the call center logging

• Conduct the quality check on the cases reported by PV assistant

• Oversee and supervise PV reporting conducted by the business partners and service vendors through reconciliation and quality check

• Handle safety information reported by NN personnel

• Distribute SUSARs to clinical development team

 

2. Assist to maintain pharmacovigilance system

• Report the HA reporting compliance to GS

• Handle customer complaint or queries related to Safety information

• Conduct quality control of customer contacts according to NN procedures

• Screen local scientific literature for capturing safety information

• Handle safety information from external websites

• Provide training regarding pharmacovigilance to internal & external stakeholders

• Handle deviations regarding affiliate PV system, if needed

• Assist in preparation of PV audit and HA inspection

• Assist in management of Safety Data Exchange Agreement(SDEA) with vendors

3. Assist in Maintenance of Risk Management Plan

• Prepare Risk Management Plan(RMP) and manage the local risk minimization measures, if needed

 

4. Back up for local QPPV

• In the absence of local QPPV, back-up the activities as per the duration

 

Requirements

 

• Bachelor’s degree in Life Science, Pharmacy, Nursing or related scientific field

• Pharmacist preferred

• At least 3 years of relevant experience in Pharmacovigilance preferred

Proficient in speaking and writing local language and English

 

Contact


Kindly 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.  

 

Millions rely on us 

 

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.


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