- 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.
- 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.