Username
Password
 
Company Info

Roche Products
4-10 Inman Road
Dee Why, Australia

Phone: 02 9454 9000
Web Site: http://careers.roche.com/australia

Company Profile


Drug Safety Associate


col-narrow   

Posted:

23.11.2017

Employment Type:

Full time

Location:

Barangaroo, NSW 

Title:

Drug Safety Associate

Category:

Drug Safety
col-wide   

Job Description:

  • Opportunity to utilise and broaden your pharmacovigilance expertise
  • Support an industry leading portfolio of products
  • Permanent opportunity, located at our new offices in Barangaroo 
The Drug Safety Department is collectively responsible for all aspects of pharmacovigilance (PV) at Roche Australia.  As a Drug Safety Associate, you will work cross-functionally with the wider affiliate to ensure PV compliance of business activities as well as evaluating and processing case reports.
 
The following are examples of some responsibilities which may form part of the role:
  • Receipt and allocation of case reports and other safety relevant information in accordance with relevant procedures and within applicable business timelines
  • Quality review of case reports processed by third party vendors or in-house ensuring compliance with applicable procedures
  • Follow-up activities on case reports as required and in accordance with relevant procedures and within applicable business timelines
  • IRT/OST workflow checks to ensure compliance with regulatory and internal business timelines for submission of case reports to TGA
  • Support the Group Drug Safety Manager in the review and update of case submission rules for Australia
  • Training of third party vendors conducting PV activities on behalf of Roche Australia and of Roche employees/contractors regarding assessment and processing of case reports and other PV activities as required

Job Requirements:

Previous Drug Safety experience within the pharmaceutical industry is necessary with an understanding of GVP principles and TGA PV regulations. In addition, you will have excellent verbal and written communication, high level of attention to detail and exceptional organisational skills.
 
Proficiency with PV systems and tools (e.g. ARISg, ARGUS) is preferred.
If you meet the above criteria, are seeking a supportive team environment and career development, we welcome your application.
 
You live our high performance culture, collaborating with the appropriate stakeholders and making well-considered decisions to achieve your goals.
 
This role is only open to candidates that have full eligibility to live and work in Australia. Please follow the link to the Roche Careers website to apply.


Company Info


Roche Products
4-10 Inman Road
Dee Why, Australia
Phone: 02 9454 9000
Web Site: http://careers.roche.com/australia

Drug Safety Associate

col-narrow   

Posted:

23.11.2017

Employment Type:

Full time

Location:

Barangaroo, NSW 

Title:

Drug Safety Associate

Category:

Drug Safety
col-wide   

Job Description:

  • Opportunity to utilise and broaden your pharmacovigilance expertise
  • Support an industry leading portfolio of products
  • Permanent opportunity, located at our new offices in Barangaroo 
The Drug Safety Department is collectively responsible for all aspects of pharmacovigilance (PV) at Roche Australia.  As a Drug Safety Associate, you will work cross-functionally with the wider affiliate to ensure PV compliance of business activities as well as evaluating and processing case reports.
 
The following are examples of some responsibilities which may form part of the role:
  • Receipt and allocation of case reports and other safety relevant information in accordance with relevant procedures and within applicable business timelines
  • Quality review of case reports processed by third party vendors or in-house ensuring compliance with applicable procedures
  • Follow-up activities on case reports as required and in accordance with relevant procedures and within applicable business timelines
  • IRT/OST workflow checks to ensure compliance with regulatory and internal business timelines for submission of case reports to TGA
  • Support the Group Drug Safety Manager in the review and update of case submission rules for Australia
  • Training of third party vendors conducting PV activities on behalf of Roche Australia and of Roche employees/contractors regarding assessment and processing of case reports and other PV activities as required

Job Requirements:

Previous Drug Safety experience within the pharmaceutical industry is necessary with an understanding of GVP principles and TGA PV regulations. In addition, you will have excellent verbal and written communication, high level of attention to detail and exceptional organisational skills.
 
Proficiency with PV systems and tools (e.g. ARISg, ARGUS) is preferred.
If you meet the above criteria, are seeking a supportive team environment and career development, we welcome your application.
 
You live our high performance culture, collaborating with the appropriate stakeholders and making well-considered decisions to achieve your goals.
 
This role is only open to candidates that have full eligibility to live and work in Australia. Please follow the link to the Roche Careers website to apply.
© 2008-2017 Powered by SmartJobBoard Job Board Software     About Us   Sitemap