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Drug Safety Systems Manager - Sweden
Posted on : 14 May 2017
- 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.
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.