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Drug Safety Systems Manager - Sweden  

SOBI (company)


Posted on : 14 May 2017

Project Description

  • Our company  is a dynamic and growing company with a high pace of change. 
  • The Drug Safety department is responsible for worldwide collection and processing adverse event reports. 
  • We manage safety data for both marketed products and products under Clinical development. 
  • The department is also responsible for conducting safety surveillance and risk management activities for our products. 
  • The products and countries we are working with as well as the complexity of our operations are continuously expanding. 
  • We are therefore now looking for a new position as Drug Safety Systems Manager to join our team.


Main areas of responsibility: 
  • Working in a cross-functional way, understand and map the business requirements to ensure necessary system support to key business processes within Drug Safety.
  • Act as Business System responsible for the global safety database and other key Drug Safety IS/IT systems including responsibilities for configuration, change control, user administration, periodic reviews, CAPA management, system development and vendor management.
  • Be responsible for data outputs and business analytics including expertise in reporting tools, reporting procedures and quality control.
  • Act as the link between the Drug Safety department, IS/IT and Quality Assurance to ensure optimal business solutions.
  • Support IS/IT projects within Drug Safety from planning to implementation and follow up, including supplier evaluations and negotiations.
  • Contribute to development of business procedures and instructions relating to system including operational activities, change control, data entry, data reporting and quality control principles.

  • Bachelor’s/Master’s degree (or equivalent) in Pharmaceutical or Biochemical Sciences, Computer Science, Engineering Science or other related degree. 
  • Pharma Industry experience and experience from working with GxP systems and computer compliance.
  • At least 3-5 years of experience in management of Information Systems for handling of clinical and/or safety data, e.g. Statisticians, Programmers or Clinical Research Managers.
  • A strategic thinker and problem solver, able to contribute and guide at an advanced level but also bringing strong operational skills and a hands-on, “get things done” attitude.
  • Strong analytical skills, able to understand complex processes.
  • Proven written and verbal communication skills, both Swedish and English.

Personal attributes:
Our values (CARE, Collaboration, Accountability, Respect, and Engagement) is the base for our daily work and your professional style should be:
  • Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies.
  • The successful candidate brings: Accountability & responsibility, Innovative thinking, Systematic approach, Initiatives & stability and finally a true Teamworking spirit.

Appointment  will take place with consideration of: 
  • Requirements of the role as it is currently framed as well as an assessment of how the post will develop; 
  • The competences, experience, personal qualities, and motivators of the candidates; 
  • The wish for our company  to secure a well-functioning group with good team dynamics, able to be successful in an international, multi-cultural and cross-border business; 
  • A wish for all employees to embrace and align with the company’s CARE values in their day-to-day operations.