(Senior) Safety Manager
This position is open at one of our offices in Norway (Oslo), Denmark (Copenhagen) or in Sweden (Lund, Stockholm or Uppsala).
LINK Medical is searching for a (Senior) Safety Manager. Our company is growing, and the portfolio of cross-functional projects is increasing. As a (Senior) Safety Manager, you will mainly manage safety activities in clinical trial projects in close collaboration with the customers or your LINK Medical colleagues. You will have the opportunity to further develop your competencies in different areas according to your aspirations and the customer’s and LINK Medical needs.
Responsibilities
You will focus on pre-marketing safety activities
- Provide safety expertise in customer services and projects, depending on your previous experience.
- Manage and execute delegated projects in an efficient and timely manner and within budget.
- Operational safety tasks e.g., handling of SAEs and reporting of SUSARs, and periodic safety reporting.
- Author Safety Management Plans, DSURs, etc.
- Medical coding
- Additional pre-marketing activities: e.g., participate in clinical trial teams, input to clinical development, advise in safety-related matters, EudraVigilance Responsible Person.
- Develop training material and conduct internal and external training.
- Active member of the Subject Matter Expert (SME) group within the Safety department, e,g., develop and maintain procedures (SOPs and WINs) related to clinical trial safety activities
- Cooperate with colleagues in LINK Medical, nationally and internationally.
- Contribute to the development of LINK Medical’s business for safety services.
Desired qualifications
- University or bachelor’s degree in natural science or similar
- 5+ years’ experience within clinical safety
- Solid theoretical and practical knowledge of clinical trial safety including regulatory requirements
- Excellent written and verbal communication skills
- Experience with customer service from a CRO or service provider is desired
- Fluent in one of the Scandinavian languages and English
- Generally good IT skills and use of standard office tools
Personal characteristics
- Able to work in a fast-paced environment with changing priorities
- Takes initiative, acts with confidence and works independently
- Takes responsibilities for actions and projects
- Develops job knowledge and expertise through continual professional development.
- Shares expertise and knowledge
- Demonstrates an interest in and understanding of others, motivates and builds team spirit
- Identifies and creates business opportunities
- Performs high quality work while maintaining professionalism and a courteous attitude with clients and colleaguesLINK Medical offers
LINK Medical offers an exciting and challenging position in a European CRO and Regulatory Service Provider that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given engaging assignments requiring efficient collaboration with industry partners, clinical and scientific teams and the regulatory authorities. We offer a competitive compensation and benefit scheme for all employees.
Contact information
If you would like to know more or have any questions about the position, please contact Berit Nautrup Andersen, Safety Director (berit.nautrup.andersen@linkmedical.eu). All applications are treated confidentially.
Last day for submitting your application: 30-Apr-2025. Application will be reviewed on an ongoing basis.