This position is open at our office in Stockholm, Sweden; Malmö, Sweden.
LINK Medical is searching for a Safety Manager. Our company is growing, and the portfolio of cross-functional projects is increasing. As a Safety Manager, you will work in close collaboration with members of several project teams and members of the Safety Group across the LINK Medical organization.
The position might require to be outsourced to clients in the greater Stockholm or Malmö area.
- As a member of the International Safety Operations team at LINK you will take part in cross-functional and cross-national pharmacovigilance activities for international project including activities such as acting as the QPPV/dQPPV, set-up of PV system, writing the PSMFs, PV SOPs and RMPs
- Perform signal detection/management including data collection, data assessment and evaluation in collaboration with e.g. medical advisors
- Handling of SAEs in clinical studies and spontaneous reports from the market, to ensure collection and assessment in accordance with LINK/customer’s SOPs and existing demands of the regulatory authorities including reporting to EudraVigilance
- Coding of AE, medical history and concomitant medication according to MedDRA and WHO Drug
- Review/write the safety section in clinical study protocols, study reports and IBs
- Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documents
- Literature search (global and local)
- Medical information handling such as being the first point of contact during office hours for receiving, handling and providing responses to medical enquiries (from customers, patients and HCPs including pharmacies) on marketed products
- Provide internal safety/pharmacovigilance support to other relevant departments
- Actively contribute to the organization and development of routines to improve the work at LINK
- Minimum Bachelor’s degree, preferably in life science or nursing; or equivalent
- At least 3 years’ experience within pharmacovigilance
- Knowledge about pharmaceuticals, medical devices, and biotech products and to understand the medical terminology and science associated with the assigned drugs and therapeutic areas
- Fluent in Swedish and English (written and oral)
- Ability to show initiative
- Ability to work independently
- Ability to work in a fast-paced environment with changing priorities
LINK Medical offers
LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams and the authorities. We offer a competitive compensation and benefit scheme for all employees.
If you would like to know more or have any questions about the position, please contact Ewa Lyzell, email@example.com or +46 (0)73 0329353.
All applications are treated confidentially.
Last day for application: 30 June 2021
Please apply to the job by filling out the application below:
Location: Stockholm, Sweden; Malmö, Sweden