– THIS JOB HAS BEEN FILLED – WE ARE NO LONGER TAKING APPLICATIONS.
The position is open at our office in Oslo, Norway.
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 Oslo area.
- As a member of the Nordic Safety team at LINK Medical you will take part in cross-functional and cross-national pharmacovigilance activities for international projects 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
- 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 Norwegian and English (written and oral)
- 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
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 a benefits scheme for all employees.
If you would like to know more or have any questions about the position, please contact Safety Group Lead,
Brit Moe, +47 92 83 86 19.
All applications are treated confidentially. Local applicants will be prioritized.
Last day for application: 23 February 2020.
Please apply to the job by filling out the application below:
LINK Medical er en konsulentvirksomhed og CRO, der dækker Skandinavien, UK og Tyskland med hovedkvarter i Oslo. Vi er i alt omkring 170 medarbejdere i LINK Medical. I den danske afdeling bliver du en del af et team på 27 kompetente kolleger, som løser opgaver inden for kliniske forsøg, Regulatory Affairs, Quality Assurance, Pharmacovigilance og Marketing Compliance.
- Internationale regulatoriske projekter.
- Mentoring & træning indenfor Regulatory eller Pharmacovigilance.
- Registreringsansøgninger, variationsansøgninger, markedsføringstilladelser m.v.
- QC af produktinformation og pakkemateriale.
- Kundekontakt og kontakt til offentlige myndigheder.
- Regulatory intelligence (lægemidler, kosttilskud og medicinsk udstyr).
- Outsourcing til RA-afdelinger hos medicinalfirmaer i Københavnsområdet.
- Andre opgaver inden for Quality Assurance og Pharmacovigilance.
- Farmaceut eller tilsvarende sundhedsfaglig uddannelse.
- 4 – 8 års regulatorisk erfaring.
- Du har gode samarbejdsegenskaber og kan lide at arbejde i teams og have kontakt med kunder og projektpersonale
- Du har højt, personligt drive og holder af nye udfordringer
- Du arbejder selvstændigt og befinder dig godt i en fleksibel organisation uden skarpe faggrænser
- Du er god til at søge viden og dygtig til at formidle den – både internt og eksternt
- Du fungerer godt i en flad organisation drevet af teamwork og engagement
Er du interesseret, så send en ansøgning med et opdateret CV til Regulatory and Safety Director; Anne Kræmmer, firstname.lastname@example.org
Du er også velkommen til at ringe for uddybende information på telefon: 6167 3215