Sobi is now recruiting a Drug Safety Manager (DSM) to the Drug Safety Operations group.
Your new role
The main responsibilities of the DSM will be to;
receipt, track, monitor and document individual case safety reports (ICSRs)
perform data entry and quality control of ICSRs within the case-handling process
provide high quality and timely contributions to responses to safety enquiries
create reports as required from the Sobi Safety Database for safety surveillance and regulatory submission activities
act as Subject Matter Expert for assigned topics for the Drug Safety Department
Further tasks might be to contribute to; review of local and global medical literature to identify individual case safety reports and other safety information related to Sobi products, development and maintenance of safety related systems and processes, follow-up, regulatory reporting, and exchange of ICSRs with internal and external sources.
What you will need to succeed
University degree in biosciences or health care
At least 1 years’ experience from the pharmaceutical industry in similar position
To be considered for this position you should have thorough knowledge of regulatory requirements, especially in the European Union. Further you should be a computer literate and fluent in English (both spoken and written). It is a clear advantage to speak Swedish.
Our Core Values (Care, Ambition, Urgency, Ownership and Partnership) is the base for our daily work. We believe you have the following personal attributes that are beneficial:
Systematic and well organized
We look forward to your application before 12th June 2018. If you have any questions, you are welcome to contact recruitment consultant Eva Bremberg at 08-120 122 76 or firstname.lastname@example.org.