Safety Manager

The position is open at our office in either Stockholm (Kista) or 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 organization. The position might require to be outsourced to clients in close proximity to your home.


Responsibilities
As a member of the Nordic Safety 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 PSMF and PV SOPs
Write RMPs in collaboration with e.g. medical advisors
Write PSUR, DSURs and other safety documents
Perform signal detection/management including data collection, data assessment and evaluation in collaboration with e.g. medical advisors
Handling of safety in clinical trials
Handling of SAE in clinical trials and spontaneous reports from the market
Review and write the safety section in clinical study protocols incl review of IBs from a safety perspective
Literature search
Electronic reporting to EudraVigilance
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
Updating of templates for safety handling in specific studies/projects according to relevant SOPs
Provide internal support to other relevant departments
Involved in improvement projects with other relevant departments
Being well-informed and updated on laws, directives and guidelines concerning safety handling

 
Desired qualifications
Minimum Bachelor’s degree, preferably in life science or nursing; or equivalent
At least 2-3 years’ experience within pharmacovigilance
Ability to show initiative
Ability to work independently
Ability to work in a fast-paced environment with changing priorities
Knowledge about pharmaceuticals 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)

 
Personal characteristics
Service minded with good cooperation and communication skills, as well as oral and written presentation skills
Well organized and structured, able to work both independently and in teams
Independent, flexible, accurate and solution oriented

 
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 salary, pension and insurance scheme and a bonus scheme for all employees.