Senior Safety Specialist/Safety Specialist

Category:  Clinical Development and Medical
Location: 

Chiyoda, Tokyo, JP

   

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

 

 

 

About the Department

 

The Department is in-charge of running all clinical development activities from initial planning of clinical trials towards authority submission. Investigates patients/subjects reaction on a given (new) drug; compares the (new) drug to already existing products;runs a set of (pre-specified) trials in human beings. Provides Biostatistics and Programming, Clinical Reporting, Data Management, Epidemiology/Real World Evidence and Clinical Pharmacology resources, processes and competences to all development projects.

 

 

The Position

 

The role of the Safety Management Department to have the following tasks to promote the proper use of health care professionals and patients, and ultimately in order to ensure effective and safety treatment of patients with Novo Nordisk products.

 

  • As the accountable person for ICSR handling based on ministerial ordinances on GVP, conduct the following actions appropriately.
    • Individual case handling for pharmaceutical products (collection of safety information, primary assessment, reporting to regulatory authorities)
    • Secondary screening of literature and academic society information
    • Education and training aimed at promoting proper use and implementation of safety assurance measures

 

  • As the accountableperson for handling of information from literature and academic society based on ministerial ordinances on GVP, and for evaluation of ADRs on Pharmaceutical drugs based on ministerial ordinances on GVP, conduct the following actions appropriately.
    • Primary screening of literature and academic society information on pharmaceuticals drugs and medical devices
    • Research report
    • Secondary evaluation of safety information on pharmaceutical drugs (individual case report, information from literature or academic society, foreign country information)
    • Instructions for accountable person for ICSR handling as necessary
    • Examine of safety assurance measures based on the evaluation result of cumulative safety data and report to safety manager

 

  • As the accountable  person for handling of information on measures taken overseas based on ministerial ordinances on GVP, and in order to properly implement safety assurance operations based on GVP ministerial ordinances, the following actions will be taken appropriately as a person accountable for document retention, conduct the following actions appropriately.

 

    • Collection, evaluation and reporting of foreign measures information on pharmaceutical drugs and medical devices
    • Consideration of action in Japan based on foreign measures information
    • Proper storage and management of GVP-related documents

 

  • Ensure that the following tasks are coordinated and appropriately conducted in accordance with national regulations in NDAS / Global Safety.
    • ICSR report to Global Safety via CCGlow
    • Review of Global SOP · Review of impact on domestic
    • Operation and maintenance of HALOPV
    • Answering to requirements, offering opinions from Japanese regulation point of view
    • SDEA conclusion, maintenance and CMS update
    • Attend to PV audit

 

 

  • Regarding PMS study aimed at re-examination applications, the following actions will be taken appropriately in Collaboration with the PMS group.
    • Protocol review
    • Create safety-related forms
    • Construction of safety information handling process and collaboration with CRO
    • Reconciliation with Global data and CRO data to our data
    • Support for smooth implementation of post-marketing surveillance
    • Respond to the request for providing information related to NN products
    • Attend to Conformity audit, GVP inspection by Tokyo Metropolitan
    • Prepare the reply for various inquiries

 

 

The Qualifications

 

  • Bachelor's degree (if possible, pharmacy or science), and experience engaging in safety management operations for at least 3 years, possibly 5 years or more, in the Safety Management Control Division (cumulative experience at other companies is acceptable)
  • Understanding of domestic regulations such as the Pharmaceuticals and Medical Devices Law, GVP, GCP, etc., and understanding foreign regulations
  • Medical and pharmaceutical knowledge related to NN products and related fields
  • Risk management capabilities
  • Excellent English skills, written and verbal, excellent organizational and time management skills, and great communication & social skills

 

 

Working at Novo Nordisk

 

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

 

Novo Nordisk is a global healthcare company with almost 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 other serious chronic conditions: haemophilia, growth disorders and obesity.

 

 

Contact

 

Please send your CV online (click on Apply and follow the instructions).

 

 

Deadline

 

We will review your applications as you apply!

 

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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