We are growing, grow with us!
Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? PharmaLex is one of the leading service providers for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance, and development consulting.
In Norway we are looking for two motivated, committed candidates to join our Pharmacovigilance and Regulatory Affairs departments. Our office is centrally located at Helsfyr in Oslo.
Pharmacovigilance and/or Regulatory Affairs Consultant
- General guidance (consultancy) of customers regarding Regulatory Submissions & Labelling
- Participation in the preparation, revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling)
- Communication with the client and the Health Authorities
- 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
- General guidance (consultancy) of customers regarding pharmacovigilance regulations and handling
We are looking for people who have experience working within either Regulatory Affairs, Pharmacovigilance, or clinical studies, but also life science graduates who are passionate about learning.
- Academic degree in pharmacy or life science
- Well organized and sense of accuracy
- Service minded, flexible, and committed to meeting deadlines
- Fluency in spoken and written Norwegian and English
- Team player
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
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.
For further information please don’t hesitate to contact us:
Manager Human Resources and Administration
Agencies only by prior agreement for the specific job opportunity.