Drug Safety Officer
TFS is a Global CRO headquartered in Sweden. We genuinely believe that “Global in mind and local at heart” is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.
Due to expansion we are now looking for a Drug Safety Officer (DSO) in Stockholm or Lund. In your first project as a DSO, you will get the opportunity to work fully sponsor dedicated with a top biopharma with Headquarter in Sweden.
In this role, you will be responsible of safety surveillance activities for the company’s products, for products in development and wherever any safety data exchange agreements exist with 3rd parties. Provide scientific and technical input to safety surveillance and risk management activities. You will also be Subject Matter Expert for safety processes, contributing to the development and maintenance of safety related processes, to support the business needs, including interactions with partners on matters relating to pharmacovigilance system and processes.
- Be the responsible DSO for specific selected Marketing Authorisation Holder products and products in development
- Be a member and coordinator of the Benefit Risk Team (BRT) meetings
- Project Manage the delivery of key safety documents, contributing to high quality and accurate documentation relevant to drug safety outputs
- Contribute to the production and maintenance of Patient Risk Management plans
- Provide high quality and timely contributions to responses to safety queries
- Lead the collection, compilation and writing of periodic safety update reports including preparation of responses to assessment reports
- Signal detection activities, involving identification, evaluation, analysis and interpretation of safety data
- Review safety sections in study protocols, IB, integrated safety summaries
- Support Medical Review for assigned projects
- Support to audits and inspections
- Liase and engage with partners
- Degree in Life Science or Health Care, Ph.D. degree is preferred
- Experience in the pharmaceutical industry working in pharmacovigilance
- Knowledge of pharmacovigilance related regulatory requirements
- Strong scientific writing skills
- Good understanding of safety reporting and pharmacovigilance compliance
- Good attention to details
- Problem solving and decision making skills
- Able to work collaboratively and independently
- High ethical standards
- Delivery focused
What can we offer you?
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.