pharmalex_job_career

We are growing, grow with us

Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life? Then make PharmaLex your career choice!
 
PharmaLex is one of the leading service providers for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance, and development consulting. We are specialised in effectively designing all aspects of drug and medicinal product registrations - ranging from early development and market entry to product maintenance activities.
 
The success of our company resides in the expert knowledge and high motivation of our employees.

We are looking for motivated, committed candidates who will enjoy working in a challenging environment. If your career is much more than just a job for you but rather your passion, then come and join our successful team. In Norway we are looking for two new members of staff to join our Pharmacovigilance and Regulatory Affairs departments. Our office is centrally located at Helsfyr in Oslo.
 

Pharmacovigilance/Regulatory Affairs Consultant

Your Job

We are looking for people who have experience working within either Regulatory Affairs, Pharmacovigilance, or clinical studies. The responsibilities will be dependent on the candidate previous experience, but will be within one or more areas as follows:
 
  • Regulatory planning, advising and implementation of marketing authorisation application procedures in the EU (MRP, DCP, CP, and national)
  • Regulatory life cycle management procedures (variations, renewals, MAH transfer etc.) worldwide
  • Participate in pre- and post-market drug safety projects
  • Management of adverse drug reactions from marketed products and clinical trials, including receipt, data entry, review, and reporting of cases
  • Production and review of periodic safety re-ports and risk management plans
  • Literature search
  • Set-up and maintain global pharmacovigilance systems

We offer you

  • Exciting and varied challenges in a friendly team, as well as many opportunities for personal development and job training
  • Flexible working hours based on trust

Your Profile

  • Academic degree in pharmacy or life science
  • At least 3 years of experience in related fields
  • Well organized and sense of accuracy
  • Service minded, flexible, and committed to meeting deadlines
  • Fluency in spoken and written Norwegian and English
  • Team player