Drug Safety Manager

Drug Safety Manager

 

Camurus is a Swedish research-based pharmaceutical company committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer, and endocrine disorders. New drug products are based on our proprietary FluidCrystal ® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”. For more information, visit camurus.com. 

At Camurus you will get the opportunity to work with committed colleagues in a team with good atmosphere, where the employees support and care for each other. Camurus is an innovative company that is currently expanding and establishing in new markets. 

We are looking for a Drug Safety Manager who will be involved in the daily internal pharmacovigilance activities. If you’re passionate and dedicated, Camurus is an excellent company for you.

Main Responsibilities:

·      Review SAEs

·      Write safety management plans

·      Co-ordinate activities in relation to safety in clinical trials

·      Review coding of adverse events, medical history and concomitant medications

·      Review SAEs in the monthly listings extracted from safety database

·      Support in preparation of clinical monthly summary of Camurus safety activities

·      Prepare and review of aggregate reports (DSURs and SUSAR line-listings)

·      Support in SOP writing by preparing and reviewing Safety/PV SOPs and other related SOPs

Candidate profile:

·      Nurse, Pharmacist, or other relevant university degree

·      Minimum of 3 – 4 years’ experience in pharmaceutical/ medical device industry within Safety and Pharmacovigilance

·      Minimum of 2 years’ experience of clinical trials and preferably SAE processing experience

·      Preferably experience of aggregate report writing and management

·      Clinical safety handling and pharmacovigilance, preferable understanding of pharmacovigilance technical documents and previous experience of using safety databases (e.g. ARISg/LSSMV or Argus), including data extraction from safety databases

·      Open-minded

·      Flexible

·      Detailed oriented

·      Constructive thinking

·      Fluent in oral and written English

·      Experienced user of MS Office package

The role is based at HQ in Lund, Sweden.

Opportunities for you
This is a great time to join a highly dynamic company during a very exciting phase of growth. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. 

Camurus has approximately 175 employees with the head office located in Lund. The corporate culture is driven by innovation, strong collaboration internally and externally, ownership, quality, and passion about realizing our ideas to achieve our patient-centric vision. 

This is an immediate, full-time employment opportunity. The application process is ongoing, so apply with your cv and cover letter as soon as possible. Please note that we do not accept applications by e-mail.

Read more about how Camurus will process your personal details here