OBS! Ansökningsperioden för denna annonsen har
passerat.
Arbetsbeskrivning
As a Drug Safety Associate at the in-house pharmacovigilance department of A+ Science you will work closely with our clients and be responsible, among others, for the following daily pharmacovigilance activities:
Management and database entry of reports of suspected adverse reactions associated with both approved and investigational medicinal products including
Expedited reporting of ICSRs and SUSARs to EudraVigilance and/or applicable Regulatory Authorities
Global and local literature review
Weekly collection of reports from EVWEB, including EMA MLM Service
Facilitate signal detection meetings
Writing and updating SOPs and WIs
Preparing PSURs/DSURs
Registration and maintenance of authorized and investigational products in the Extended EudraVigilance medicinal product dictionary (XEVMPD) is desired, although not a requirement
Other responsibilities as required
Desired skills and qualifications:
An academic degree within medicine, pharmacy, biology or equivalent (e.g. biomedicine, physician, pharmacist, nurse)
Relevant experience within pharmacovigilance
Deep knowledge of the pharmacovigilance legislation, e.g. EMA’s guideline on good pharmacovigilance practices (GVP)
Computer proficiency
Good verbal and written communication and presentation skills
Fluent in Swedish and English
You have a sense for accuracy and structure as well as a flexible and open mindset
Leadership and project management qualities are desired, although not a requirement
We offer you long term commitment with development opportunities in a unique CRO run by its ambitious, enthusiastic and dedicated colleagues.
Please send your CV and application letter to our HR Consultant Malin Ung, email malin.ung@hrskills.se
We very much appreciate not to be contacted by recruitment agencies for the above position